Peripheral Arterial DiseaseNCT02923193
Shockwave Medical Peripheral Lithoplasty System Study for PAD (Disrupt PAD III)
A study testing Shockwave Lithoplasty® Peripheral Lithoplasty System and Medtronic IN.PACT (DCB) in people with Peripheral Arterial Disease, run by Shockwave Medical, Inc. at 54 sites in 4 countries.
Trial summary
Shockwave Medical Inc. intends to conduct a prospective, multi-center, single blind, randomized (1:1) study of Lithoplasty treatment used in combination with DCB versus standard balloon angioplasty used in combination with DCB to treat moderate and severely calcified femoropopliteal arteries. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Peripheral Arterial Disease
- What is being tested?
- Shockwave Lithoplasty® Peripheral Lithoplasty System and Medtronic IN.PACT (DCB)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 306 participants
- Where
- 54 sitesin 4 countries
- Study dates
- 22 Feb 2017to 2 Jun 2022
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects intended to be treated with the Shockwave Medical Peripheral Lithoplasty® System for de-novo or restenotic lesions of the femoral, ilio-femoral, popliteal, and infra-popliteal arteries.
- Subjects presenting with claudication or CLI by Rutherford Clinical Category 2,3,4,5, or 6 of the target limb.
- Age of subject is > 18.
- Subject or subject's legal representative have been informed of the nature of the study, agrees to participate, and has signed the approved study consent form.
- Calcification is at least moderate, defined as presence of fluoroscopic evidence of calcification: 1) on parallel sides of the vessel and 2) extending > 50% the length of the lesion if lesion is ≥50mm in length; or extending for minimum of 20mm if lesion is <50mm in length.
Who cannot join
- Subjects with any medical condition that would make him/her an inappropriate candidate for treatment with Shockwave Medical Peripheral Lithoplasty® System as per Instructions for Use (IFU) or investigator's opinion.
- Subject is already enrolled in other investigational (interventional) studies that would interfere with study endpoints.
Trial locations and contacts
54 sites in 4 countries.
54 sites in 4 countries
United States40 sites
Piedmont Heart Institute
Atlanta, Georgia, 30309
Rocky Mountain Regional VA Medical Center
Aurora, Colorado, 80045
St. David's Heart and Vascular dba Austin Heart
Austin, Texas, 78756
St. John Clinic
Bartlesville, Oklahoma, 74006
Steward St. Elizabeth's Medical Center
Brighton, Maine, 02135
Deborah Heart and Lung Center
Browns Mills, New Jersey, 08015
Bryn Mawr Hospital
Bryn Mawr, Pennsylvania, 19010
Charleston Area Medical Center
Charleston, West Virginia, 25304
Ohio Health Research Institute
Columbus, Ohio, 43214
Midwest Cardiovascular Research Foundation
Davenport, Iowa, 52803
Alexian Brothers Medical Center
Elk Grove Village, Illinois, 60007
Northeast Georgia Medical Center
Gainesville, Georgia, 30501
PinnacleHealth Harrisburg Hospital
Harrisburg, Pennsylvania, 17101
Baylor College of Medicine
Houston, Texas, 77030
Saint Luke's Cardiovascular Consultants
Kansas City, Missouri, 64111
Wellmont CVA Heart Institute
Kingsport, Tennessee, 37660
Tennova Healthcare - Turkey Creek Medical Center
Knoxville, Tennessee, 37934
St. Luke's East Hospital
Lee's Summit, Missouri, 64086
Arkansas Heart Hospital
Little Rock, Arkansas, 72211
UCHealth Northern Colorado
Loveland, Colorado, 80538
Baptist Medical Center
Memphis, Tennessee, 38120
Advocate Health and Hospitals Corporation
Naperville, Illinois, 60540
Yale New Haven Hospital
New Haven, Connecticut, 06510
Mount Sinai West
New York, New York, 10019
Icahn School of Medicine at Mount Sinai
New York, New York, 10029
Columbia University Medical Center/New York Presbyterian Hospital
New York, New York, 10032
Stanford Hospital
Palo Alto, California, 94304
Einstein Medical Center Philadelphia
Philadelphia, Pennsylvania, 19141
St. Joseph Mercy Oakland
Pontiac, Michigan, 48431
Providence Portland Medical Center
Portland, Oregon, 97213
Providence Heart & Vascular Institute
Portland, Oregon, 97225
The Miriam Hospital
Providence, Rhode Island, 02906
NC Heart & Vascular Research
Raleigh, North Carolina, 27607
WakeMed Health & Hospitals
Raleigh, North Carolina, 27610
Ascension / St. John Providence
Southfield, Michigan, 48075
Prairie Education & Research Cooperative
Springfield, Illinois, 62769
Tallahassee Research Institute, Inc.
Tallahassee, Florida, 32308
North Mississippi Medical Center
Tupelo, Mississippi, 38801
MedStar Cardiovascular Research Network @ Medstar Washington Hospital Center
Washington D.C., District of Columbia, 20010
Lankenau Institute for Medical Research
Wynnewood, Pennsylvania, 19096
Germany11 sites
Karolinen-Hospital
Arnsberg, 59759
Universitäts-Herzzentrum Freiburg & Bad Krozingen
Bad Krozingen, 79189
Sankt Gertrauden-Krankenhaus
Berlin, 10713
Leiter Sektion Angiologie
Bonn, 53127
Medizinische Klinik II
Bruchsal, 76646
Klinik für Gefäßmedizin
Hamburg, 21075
Universitätsklinikum Leipzig AoR Leipzig
Leipzig, 04103
Katholisches Klinikum Mainz
Mainz, 55131
Evangelisches Krankenhaus Mühlheim an der Ruhr
Mülheim, 45468
St. Franziskus Hospital
Münster, 48145
RoMed Klinikum Rosenheim
Rosenheim, 83022
Austria2 sites
Medizinische Universitaet Graz
Graz, 8036
Gefäßsambulanz
Vienna, 1140
About this study
Official title: Randomized Study of the Shockwave Medical Peripheral Lithoplasty® System Used in Combination With DCB Versus Standard Balloon Angioplasty Used in Combination With DCB to Treat Moderate and Severely Calcified Femoropopliteal Arteries
Shockwave Medical Inc. intends to conduct a prospective, multi-center, single blind, randomized (1:1) study of Lithoplasty treatment used in combination with DCB versus standard balloon angioplasty used in combination with DCB to treat moderate and severely calcified femoropopliteal arteries. Assuming that roughly 15% of the subjects will be lost-to-follow-up, a total of up to 400 subjects (200 per treatment arm) will be enrolled in the study at up to 60 sites in Europe, the United States and New Zealand.
In addition to the randomized study, an observational study of subjects who do not meet the inclusion/exclusion criteria for the randomized study will be conducted. The objective of the observational study is to assess the real-world acute performance of the Shockwave Medical Peripheral Lithoplasty System in the treatment of calcified, stenotic, peripheral arteries.
Read more
The observational study is a prospective, multi-center, single arm observational study for subjects who do not meet the inclusion/exclusion criteria of the randomized study.
A maximum of 1500 subjects at the same 60 sites will be enrolled in the observational study. Once enrollment in the randomized portion of the study is complete, subjects may continue to be enrolled in the observational study provided they meet OS eligibility criteria.
Results for the observational study will be reported in a separate record under NCT05881421.
Read the detailed description
Shockwave Medical Inc. intends to conduct a prospective, multi-center, single blind, randomized (1:1) study of Lithoplasty treatment used in combination with DCB versus standard balloon angioplasty used in combination with DCB to treat moderate and severely calcified femoropopliteal arteries. The Shockwave Medical Peripheral Lithoplasty System is indicated for lithotripsy-enhanced, low-pressure balloon dilatation of calcified, stenotic peripheral arteries in patients who are candidates for percutaneous therapy. Up to 400 subjects at 60 sites in Europe, the United States and New Zealand.
Subjects will be followed through discharge, 30 days, and 6, 12 and 24 months. DUS assessments will be completed at 12 and 24 months. Procedural success is defined as residual stenosis ≤30% without flow-limiting dissection (≥ grade D) prior to DCB or stenting by angiographic core lab.
Subjects who do not meet the randomized study inclusion and exclusion criteria, but meet the inclusion and exclusion criteria for the observational study may be enrolled in the observational study. The objective of the observational study is to assess the real-world acute performance of the Shockwave Medical Lithoplasty System in the treatment of calcified, stenotic, peripheral arteries.The observational study is a prospective, multi-center, single arm observational study for subjects who do not meet the inclusion/exclusion criteria of the randomized study. A maximum of 1500 subjects at the same 60 sites will be enrolled in the observational study. Procedural success is defined as residual stenosis ≤30% without flow-limiting dissection (≥ grade D) prior to DCB or stenting by angiographic core lab. Enrollment in the observational study is anticipated to last approximately 22 months. Subjects in the observational study will be followed through hospital discharge. Once enrollment in the randomized portion of the study is complete, subjects may continue to be enrolled in the observational study provided they meet OS eligibility criteria. Results for the observational study will be reported in a separate record under NCT05881421.
- Conditions
- Peripheral Arterial Disease
- Being tested
- Shockwave Lithoplasty® Peripheral Lithoplasty System, Medtronic IN.PACT (DCB)
- Medical subject headings
- Peripheral Arterial Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Shockwave Lithoplasty® Peripheral Lithoplasty SystemDevice
The Shockwave Lithoplasty® System is a proprietary lithotripsy-enhanced balloon catheter that is designed to be delivered through the peripheral arterial system of the lower extremities to the site of calcified stenosis. Activating the lithotripsy within the device will generate pulsatile mechanical energy within the target treatment site, disrupt calcium within the lesion and allow subsequent dilation of a peripheral artery stenosis using low balloon pressure. The system consists of a balloon catheter with multiple integrated lithotripsy electrodes, and a generator.
Medtronic IN.PACT (DCB)Drug
Also called drug coated balloon
The IN.PACT Admiral DCB is an over-the-wire (OTW) balloon catheter with a drug-coated balloon at the distal tip. The drug component, referred to as the FreePac™ drug coating, consists of the drug paclitaxel and the excipient urea. The device component physically dilates the vessel lumen by PTA, and the drug is intended to reduce the proliferative response that is associated with restenosis.
| Study group | Role | What they receive |
|---|---|---|
| Lithoplasty System followed by DCB | Experimental | Shockwave Lithoplasty® Peripheral Lithoplasty System is a lithotripsy-enhanced, low-pressure balloon dilatation of calcified, stenotic peripheral arteries in patients who are candidates for percutaneous therapy. lithoplasty Receives: Device: Shockwave Lithoplasty® Peripheral Lithoplasty System; Drug: Medtronic IN.PACT (DCB) |
| Medtronic IN.PACT (DCB) | Active comparator | Medronic IN.PACT Drug Coated Balloon (DBS) is indicated for percutaneous transluminal angioplasty (PTA) in patients with obstructive disease of peripheral arteries, including patients with in-stent restenosis (ISR) and arteriovenous (AV) access to help maintain hemodialysis access in patients with end-stage renal disease. Receives: Drug: Medtronic IN.PACT (DCB) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Procedural Success
Procedural success is defined as residual stenosis ≤30% without flow-limiting dissection (≥ grade D) prior to DCB or stenting by angiographic core lab.
Measured: Peri-Procedural, approximately 2 hours
Secondary outcomes (22)
Number of Participants With Major Adverse Events (MAEs)
- Need for emergency surgical revascularization of target limb
- Unplanned target limb major amputation (above the ankle)
- Symptomatic thrombus or distal emboli that require surgical, mechanical or pharmacologic means to improve flow and extend hospitalization
- Perforations that require an intervention, including bail-out stenting
Measured: 30 days
Clinical Success ABI
Defined as ankle-brachial index ABI reported at 30 days as change from baseline. The ABI is the ratio of systolic blood pressure measured at the ankle to systolic blood pressure measured at the brachial artery. Ideally, this ratio should be 1.0, but is often less in a subject with peripheral arterial disease.
Measured: 30 days
Clinical Success Quality of Life
Defined by Quality of Life assessed by EQ5D questionnaire reported at 30 days as change from baseline. The EQ-5D-3L descriptive system comprises the following five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 3 levels: no problems, some problems, and extreme problems. The patient is asked to indicate his/her health state by ticking the box next to the most appropriate statement in each of the five dimensions. The overall summary index (from Shaw et. al.) computed from the 5-dimension sub-scores was applied. It ranges from 0.000 to 1.000; higher scores indicate better patient-reported health status."
Measured: 30 days
Clinical Success Rutherford Category
Defined as Rutherford Category reported at 30 days as change from baseline. Clinical scale identifying three grades of claudication and three grades of critical limb ischemia ranging from rest pain alone to minor and major tissue loss. 0 is asymptomatic and 6 is ulcers/gangrene.
Measured: 30 days
Number of Participants With Clinically-driven Target Lesion Revascularization (TLR)
Any revascularization (endovascular or surgical) within the target femoropopliteal vessel due to symptoms or drop of ABI >20% or >0.15 when compared to the 30-day ABI and associated with an angiographic lesion >50% at the target lesion site
Measured: 30 days
Number of Participants With Major Adverse Events (MAEs)
- Need for emergency surgical revascularization of target limb
- Unplanned target limb major amputation (above the ankle)
- Symptomatic thrombus or distal emboli that require surgical, mechanical or pharmacologic means to improve flow and extend hospitalization
- Perforations that require an intervention, including bail-out stenting
Measured: 6 months
Clinical Success Rutherford Category
Defined as Rutherford Category reported at 6 months as change from baseline. Clinical scale identifying three grades of claudication and three grades of critical limb ischemia ranging from rest pain alone to minor and major tissue loss. 0 is asymptomatic and 6 is ulcers/gangrene.
Measured: 6 months
Number of Participants With Clinically-driven Target Lesion Revascularization (TLR)
Any revascularization (endovascular or surgical) within the target femoropopliteal vessel due to symptoms or drop of ABI >20% or >0.15 when compared to the 30-day ABI and associated with an angiographic lesion >50% at the target lesion site
Measured: 6 months
Clinical Success ABI
Defined as ankle-brachial index ABI reported at 6 months as change from baseline. The ABI is the ratio of systolic blood pressure measured at the ankle to systolic blood pressure measured at the brachial artery. Ideally, this ratio should be 1.0, but is often less in a subject with peripheral arterial disease.
Measured: 6 months
Clinical Success Quality of Life
Defined by Quality of Life assessed by EQ5D questionnaire reported at 6 months as change from baseline. The EQ-5D-3L descriptive system comprises the following five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 3 levels: no problems, some problems, and extreme problems. The patient is asked to indicate his/her health state by ticking the box next to the most appropriate statement in each of the five dimensions. The overall summary index (from Shaw et. al.) computed from the 5-dimension sub-scores was applied and ranges from 0.000 to 1.000; higher scores indicate better patient-reported health status.
Measured: 6 months
Number of Participants With Primary Patency
Defined as freedom from clinically-driven target lesion revascularization (TLR) and freedom from restenosis determined by duplex ultrasound or angiogram greater than or equal to 50% stenosis.
Measured: 12 months
Number of Participants With Major Adverse Events (MAEs)
- Need for emergency surgical revascularization of target limb
- Unplanned target limb major amputation (above the ankle)
- Symptomatic thrombus or distal emboli that require surgical, mechanical or pharmacologic means to improve flow and extend hospitalization
- Perforations that require an intervention, including bail-out stenting
Measured: 12 months
Number of Participants With Clinically-driven Target Lesion Revascularization (TLR)
Any revascularization (endovascular or surgical) within the target femoropopliteal vessel due to symptoms or drop of ABI >20% or >0.15 when compared to the 30-day ABI and associated with an angiographic lesion >50% at the target lesion site
Measured: 12 months
Clinical Success ABI
Defined as ankle-brachial index ABI reported at 12 months as change from baseline. The ABI is the ratio of systolic blood pressure measured at the ankle to systolic blood pressure measured at the brachial artery. Ideally, this ratio should be 1.0, but is often less in a subject with peripheral arterial disease.
Measured: 12 months
Clinical Success Rutherford Category
Defined as Rutherford Category reported at 12 months as change from baseline. Clinical scale identifying three grades of claudication and three grades of critical limb ischemia ranging from rest pain alone to minor and major tissue loss. 0 is asymptomatic and 6 is ulcers/gangrene.
Measured: 12 months
Clinical Success Quality of Life
Defined by Quality of Life assessed by EQ5D questionnaire reported at 12 months as change from baseline. The EQ-5D-3L descriptive system comprises the following five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 3 levels: no problems, some problems, and extreme problems. The patient is asked to indicate his/her health state by ticking the box next to the most appropriate statement in each of the five dimensions. The overall summary index (from Shaw et. al.) computed from the 5-dimension sub-scores was applied and ranges from 0.000 to 1.000; higher scores indicate better patient-reported health status.
Measured: 12 months
Number of Participants With Primary Patency
Defined as freedom from clinically-driven target lesion revascularization (TLR) and freedom from restenosis determined by duplex ultrasound or angiogram greater than or equal to 50% stenosis.
Measured: 24 months
Number of Participants With Major Adverse Events (MAEs)
- Need for emergency surgical revascularization of target limb
- Unplanned target limb major amputation (above the ankle)
- Symptomatic thrombus or distal emboli that require surgical, mechanical or pharmacologic means to improve flow and extend hospitalization
- Perforations that require an intervention, including bail-out stenting
Measured: 24 months
Number of Participants With Clinically-driven Target Lesion Revascularization (TLR)
Any revascularization (endovascular or surgical) within the target femoropopliteal vessel due to symptoms or drop of ABI >20% or >0.15 when compared to the 30-day ABI and associated with an angiographic lesion >50% at the target lesion site
Measured: 24 months
Clinical Success ABI
Defined as ankle-brachial index ABI reported at 24 months as change from baseline. The ABI is the ratio of systolic blood pressure measured at the ankle to systolic blood pressure measured at the brachial artery. Ideally, this ratio should be 1.0, but is often less in a subject with peripheral arterial disease.
Measured: 24 months
Clinical Success Rutherford Category
Defined as Rutherford Category reported at 24 months as change from baseline. Clinical scale identifying three grades of claudication and three grades of critical limb ischemia ranging from rest pain alone to minor and major tissue loss. 0 is asymptomatic and 6 is ulcers/gangrene.
Measured: 24 months
Clinical Success Quality of Life
Defined by Quality of Life assessed by EQ5D questionnaire reported at 24 months as change from baseline. The EQ-5D-3L descriptive system comprises the following five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 3 levels: no problems, some problems, and extreme problems. The patient is asked to indicate his/her health state by ticking the box next to the most appropriate statement in each of the five dimensions. The overall summary index (from Shaw et. al.) computed from the 5-dimension sub-scores was applied and ranges from 0.000 to 1.000; higher scores indicate better patient-reported health status.
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Oct 2016 (estimated)
- Study start22 Feb 2017
- Primary completion12 May 2020
- Study completion2 Jun 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Peripheral Arterial DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 306 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shockwave Medical, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Gunnar Tepe, MD, Principal investigator, RoMed Klinikum RosenheimWilliam A Gray, MD, Principal investigator, Main Line Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02923193
- Sponsor's protocol ID
- CP 60892
- Status last verified
- Dec 2023
- First submitted
- 28 Sep 2016
- Last updated
- 20 Dec 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Nagpal S, Altin SE, McGinigle K, Mangalmurti SS, Adams G, Shammas NW, Mehrle A, Soukas P, Bertolet B, Lansky AJ. Sex-specific analysis of intravascular lithotripsy for peripheral artery disease from the Disrupt PAD III observational study. J Vasc Surg. 2024 Feb;79(2):358-365. doi: 10.1016/j.jvs.2023.10.058. Epub 2023 Nov 2.
PubMed 37925039Tepe G, Brodmann M, Werner M, Bachinsky W, Holden A, Zeller T, Mangalmurti S, Nolte-Ernsting C, Bertolet B, Scheinert D, Gray WA; Disrupt PAD III Investigators. Intravascular Lithotripsy for Peripheral Artery Calcification: 30-Day Outcomes From the Randomized Disrupt PAD III Trial. JACC Cardiovasc Interv. 2021 Jun 28;14(12):1352-1361. doi: 10.1016/j.jcin.2021.04.010.
PubMed 34167675Adams G, Shammas N, Mangalmurti S, Bernardo NL, Miller WE, Soukas PA, Parikh SA, Armstrong EJ, Tepe G, Lansky A, Gray WA. Intravascular Lithotripsy for Treatment of Calcified Lower Extremity Arterial Stenosis: Initial Analysis of the Disrupt PAD III Study. J Endovasc Ther. 2020 Jun;27(3):473-480. doi: 10.1177/1526602820914598. Epub 2020 Apr 3.
PubMed 32242768
Study at a glance
From the registry record, last updated by the sponsor on 20 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Study of the Shockwave Medical Peripheral Lithoplasty® System Used in Combination With DCB Versus Standard Balloon Angioplasty Used in Combination With DCB to Treat Moderate and Severely Calcified Femoropopliteal Arteries
- ClinicalTrials.gov ID
- NCT02923193
- Acronym / sponsor ID
- CP 60892
- Conditions
- Peripheral Arterial Disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 306 participants (actual)
- Lead sponsor
- Shockwave Medical, Inc.Industry (pharma, biotech, devices)
- Study start
- 22 Feb 2017 (actual)
- Primary completion
- 12 May 2020 (actual)
- Study completion
- 2 Jun 2022 (actual)
- First posted
- 4 Oct 2016 (estimated)
- Results
- Posted 20 Dec 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Shockwave Medical Inc. intends to conduct a prospective, multi-center, single blind, randomized (1:1) study of Lithoplasty treatment used in combination with DCB versus standard balloon angioplasty used in combination with DCB to treat moderate and severely calcified femoropopliteal arteries. Assuming that roughly 15% of the subjects will be lost-to-follow-up, a total of up to 400 subjects (200 per treatment arm) will be enrolled in the study at up to 60 sites in Europe, the United States and New Zealand.
In addition to the randomized study, an observational study of subjects who do not meet the inclusion/exclusion criteria for the randomized study will be conducted. The objective of the observational study is to assess the real-world acute performance of the Shockwave Medical Peripheral Lithoplasty System in the treatment of calcified, stenotic, peripheral arteries.
The observational study is a prospective, multi-center, single arm observational study for subjects who do not meet the inclusion/exclusion criteria of the randomized study.
A maximum of 1500 subjects at the same 60 sites will be enrolled in the observational study. Once enrollment in the randomized portion of the study is complete, subjects may continue to be enrolled in the observational study provided they meet OS eligibility criteria.
Results for the observational study will be reported in a separate record under NCT05881421.
Detailed description
Shockwave Medical Inc. intends to conduct a prospective, multi-center, single blind, randomized (1:1) study of Lithoplasty treatment used in combination with DCB versus standard balloon angioplasty used in combination with DCB to treat moderate and severely calcified femoropopliteal arteries. The Shockwave Medical Peripheral Lithoplasty System is indicated for lithotripsy-enhanced, low-pressure balloon dilatation of calcified, stenotic peripheral arteries in patients who are candidates for percutaneous therapy. Up to 400 subjects at 60 sites in Europe, the United States and New Zealand.
Subjects will be followed through discharge, 30 days, and 6, 12 and 24 months. DUS assessments will be completed at 12 and 24 months. Procedural success is defined as residual stenosis ≤30% without flow-limiting dissection (≥ grade D) prior to DCB or stenting by angiographic core lab.
Subjects who do not meet the randomized study inclusion and exclusion criteria, but meet the inclusion and exclusion criteria for the observational study may be enrolled in the observational study. The objective of the observational study is to assess the real-world acute performance of the Shockwave Medical Lithoplasty System in the treatment of calcified, stenotic, peripheral arteries.The observational study is a prospective, multi-center, single arm observational study for subjects who do not meet the inclusion/exclusion criteria of the randomized study. A maximum of 1500 subjects at the same 60 sites will be enrolled in the observational study. Procedural success is defined as residual stenosis ≤30% without flow-limiting dissection (≥ grade D) prior to DCB or stenting by angiographic core lab. Enrollment in the observational study is anticipated to last approximately 22 months. Subjects in the observational study will be followed through hospital discharge. Once enrollment in the randomized portion of the study is complete, subjects may continue to be enrolled in the observational study provided they meet OS eligibility criteria. Results for the observational study will be reported in a separate record under NCT05881421.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Lithoplasty System followed by DCB | Experimental | Device: Shockwave Lithoplasty® Peripheral Lithoplasty System, Drug: Medtronic IN.PACT (DCB)Shockwave Lithoplasty® Peripheral Lithoplasty System is a lithotripsy-enhanced, low-pressure balloon dilatation of calcified, stenotic peripheral arteries in patients who are candidates for percutaneous therapy. lithoplasty |
| Medtronic IN.PACT (DCB) | Active comparator | Drug: Medtronic IN.PACT (DCB)Medronic IN.PACT Drug Coated Balloon (DBS) is indicated for percutaneous transluminal angioplasty (PTA) in patients with obstructive disease of peripheral arteries, including patients with in-stent restenosis (ISR) and arteriovenous (AV) access to help maintain hemodialysis access in patients with end-stage renal disease. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Subjects intended to be treated with the Shockwave Medical Peripheral Lithoplasty® System for de-novo or restenotic lesions of the femoral, ilio-femoral, popliteal, and infra-popliteal arteries.
- Subjects presenting with claudication or CLI by Rutherford Clinical Category 2,3,4,5, or 6 of the target limb.
- Age of subject is > 18.
- Subject or subject's legal representative have been informed of the nature of the study, agrees to participate, and has signed the approved study consent form.
- Calcification is at least moderate, defined as presence of fluoroscopic evidence of calcification: 1) on parallel sides of the vessel and 2) extending > 50% the length of the lesion if lesion is ≥50mm in length; or extending for minimum of 20mm if lesion is <50mm in length.
Key exclusion criteria (2 listed)
- Subjects with any medical condition that would make him/her an inappropriate candidate for treatment with Shockwave Medical Peripheral Lithoplasty® System as per Instructions for Use (IFU) or investigator's opinion.
- Subject is already enrolled in other investigational (interventional) studies that would interfere with study endpoints.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Shockwave Lithoplasty® Peripheral Lithoplasty SystemThe Shockwave Lithoplasty® System is a proprietary lithotripsy-enhanced balloon catheter that is designed to be delivered through the peripheral arterial system of the lower extremities to the site of calcified stenosis. Activating the lithotripsy within the device will generate pulsatile mechanical energy within the target treatment site, disrupt calcium within the lesion and allow subsequent dilation of a peripheral artery stenosis using low balloon pressure. The system consists of a balloon catheter with multiple integrated lithotripsy electrodes, and a generator. | Device | Lithoplasty System followed by DCB |
| Medtronic IN.PACT (DCB)Also: drug coated balloonThe IN.PACT Admiral DCB is an over-the-wire (OTW) balloon catheter with a drug-coated balloon at the distal tip. The drug component, referred to as the FreePac™ drug coating, consists of the drug paclitaxel and the excipient urea. The device component physically dilates the vessel lumen by PTA, and the drug is intended to reduce the proliferative response that is associated with restenosis. | Drug | Lithoplasty System followed by DCB, Medtronic IN.PACT (DCB) |
Primary outcome
Number of Participants With Procedural Success
Time frame: Peri-Procedural, approximately 2 hours
Procedural success is defined as residual stenosis ≤30% without flow-limiting dissection (≥ grade D) prior to DCB or stenting by angiographic core lab.
22 secondary outcomes
Number of Participants With Major Adverse Events (MAEs)
Time frame: 30 days
Clinical Success ABI
Time frame: 30 days
Clinical Success Quality of Life
Time frame: 30 days
Clinical Success Rutherford Category
Time frame: 30 days
Number of Participants With Clinically-driven Target Lesion Revascularization (TLR)
Time frame: 30 days
Number of Participants With Major Adverse Events (MAEs)
Time frame: 6 months
Clinical Success Rutherford Category
Time frame: 6 months
Number of Participants With Clinically-driven Target Lesion Revascularization (TLR)
Time frame: 6 months
Clinical Success ABI
Time frame: 6 months
Clinical Success Quality of Life
Time frame: 6 months
Number of Participants With Primary Patency
Time frame: 12 months
Number of Participants With Major Adverse Events (MAEs)
Time frame: 12 months
Number of Participants With Clinically-driven Target Lesion Revascularization (TLR)
Time frame: 12 months
Clinical Success ABI
Time frame: 12 months
Clinical Success Rutherford Category
Time frame: 12 months
Clinical Success Quality of Life
Time frame: 12 months
Number of Participants With Primary Patency
Time frame: 24 months
Number of Participants With Major Adverse Events (MAEs)
Time frame: 24 months
Number of Participants With Clinically-driven Target Lesion Revascularization (TLR)
Time frame: 24 months
Clinical Success ABI
Time frame: 24 months
Clinical Success Rutherford Category
Time frame: 24 months
Clinical Success Quality of Life
Time frame: 24 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Dec 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 37925039Nagpal S, Altin SE, McGinigle K, Mangalmurti SS, Adams G, Shammas NW, Mehrle A, Soukas P, Bertolet B, Lansky AJ. Sex-specific analysis of intravascular lithotripsy for peripheral artery disease from the Disrupt PAD III observational study. J Vasc Surg. 2024 Feb;79(2):358-365. doi: 10.1016/j.jvs.2023.10.058. Epub 2023 Nov 2.
- Derived from this study: PubMed 34167675Tepe G, Brodmann M, Werner M, Bachinsky W, Holden A, Zeller T, Mangalmurti S, Nolte-Ernsting C, Bertolet B, Scheinert D, Gray WA; Disrupt PAD III Investigators. Intravascular Lithotripsy for Peripheral Artery Calcification: 30-Day Outcomes From the Randomized Disrupt PAD III Trial. JACC Cardiovasc Interv. 2021 Jun 28;14(12):1352-1361. doi: 10.1016/j.jcin.2021.04.010.
- Derived from this study: PubMed 32242768Adams G, Shammas N, Mangalmurti S, Bernardo NL, Miller WE, Soukas PA, Parikh SA, Armstrong EJ, Tepe G, Lansky A, Gray WA. Intravascular Lithotripsy for Treatment of Calcified Lower Extremity Arterial Stenosis: Initial Analysis of the Disrupt PAD III Study. J Endovasc Ther. 2020 Jun;27(3):473-480. doi: 10.1177/1526602820914598. Epub 2020 Apr 3.
- Intravascular lithotripsy for treatment of calcified, stenotic iliac arteries: A cohort analysis from the Disrupt PAD III StudyLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gunnar Tepe, MD principal investigator
RoMed Klinikum Rosenheim
William A Gray, MD principal investigator
Main Line Health
54 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Shockwave Lithoplasty® Peripheral Lithoplasty System and Medtronic IN.PACT (DCB) in people with Peripheral Arterial Disease, run by Shockwave Medical, Inc. at 54 sites in 4 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 54 sites in United States, Germany, Austria, New Zealand. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 20 Dec 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants With Procedural Success (time frame: Peri-Procedural, approximately 2 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02923193, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Dec 2023.