Femoral Artery StenosisCONFIRMNCT02813577
Lutonix Drug Coated Balloon for Treatment of Femoropopliteal Arteries in United States Females (CONFIRM)
A study testing Lutonix® 035 Drug Coated Balloon PTA Catheter in people with Femoral Artery Stenosis and Popliteal Artery Stenosis, run by C. R. Bard at 4 sites in United States.
Trial summary
The post approval study will enroll US female patients presenting with claudication or ischemic rest pain and an angiographically significant lesion in the superficial femoral or popliteal artery. Subjects are treated per Instructions For Use (IFU) with the Lutonix® Catheter. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Femoral Artery Stenosis, Popliteal Artery Stenosis, Femoral Artery Occlusion
- What is being tested?
- Lutonix® 035 Drug Coated Balloon PTA Catheter
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 4 participants
- Where
- 4 sitesUnited States
- Study dates
- 20 Apr 2018to 18 Feb 2019
- 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
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
None listed.
Who cannot join
- Life expectancy of <2 years;
- Subject is currently participating in an investigational drug or device study, or previously enrolled in this study. Enrollment in another investigational drug or device study during the follow up period is not allowed;
- History of stroke within 3 months;
- History of myocardial infarction (MI), thrombolysis or angina within 2 weeks of index procedure;
- Renal failure or chronic kidney disease with serum creatinine ≥2.5 mg/L within 30 days of index procedure or treated with dialysis;
- Sudden symptom onset, acute vessel occlusion, or acute or sub-acute thrombus in target vessel.
Trial locations and contacts
4 sites in 1 country.
United States4 sites
Midwest Cardiovascular Research Foundation
Davenport, Iowa, 52803
St. Vincent Medical Group
Indianapolis, Indiana, 46290
Wellmont CVA Heart Institute
Kingsport, Tennessee, 37660
Vascular Access Solutions
Orangeburg, South Carolina, 29118
About this study
Official title: A Prospective, Multicenter, Single Arm, Post-Approval Study of the Lutonix Drug Coated Balloon for Treatment of Femoropopliteal Arteries in United States Females
The post approval study will enroll US female patients presenting with claudication or ischemic rest pain and an angiographically significant lesion in the superficial femoral or popliteal artery. Subjects are treated per Instructions For Use (IFU) with the Lutonix® Catheter. Subjects will have a Duplex Ultrasound (DUS) and clinical follow-up through two (2) years.
Read the detailed description
The Lutonix® 035 Drug Coated Balloon PTA Catheter (Lutonix® Catheter) has been approved by the Food and Drug Administration (P130024) for percutaneous transluminal angioplasty, after appropriate vessel preparation of de novo, restenotic, or in-stent restenotic lesions up to 300 mm in length in native superficial femoral or popliteal arteries with reference vessel diameters of 4-7 mm. The purpose of this post-approval study is to assess the safety and effectiveness of the Lutonix® Catheter in the US female population. This study will enroll approximately 165 female patients at a minimum of 10 US centers and a maximum of 25.
- Conditions
- Femoral Artery Stenosis, Popliteal Artery Stenosis, Femoral Artery Occlusion, Popliteal Artery Occlusion
- Being tested
- Lutonix® 035 Drug Coated Balloon PTA Catheter
- Keywords
- Legs, Drug Coated Angioplasty Balloon, Experimental, Standard Angioplasty Balloon
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lutonix® 035 Drug Coated Balloon PTA CatheterDevice
Female subjects will receive the Lutonix® 035 Drug Coated Balloon PTA Catheter.
| Study group | Role | What they receive |
|---|---|---|
| Lutonix® 035 Drug Coated Balloon PTA Catheter | Other | This is a single-arm study. Female subjects will receive the Lutonix® 035 Drug Coated Balloon PTA Catheter. Receives: Device: Lutonix® 035 Drug Coated Balloon PTA Catheter |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Freedom From the Following: All-cause Peri-operative Death at 30 Days, Index Limb Amputation Within 1 Year, Index Limb Re-intervention Within 1 Year, and Index-limb-Related Death Within 1 Year Post Index Procedure
Index limb amputation includes above or below the ankle amputations.
Measured: 12 months post index procedure
Effectiveness: Number of Participants With Primary Patency of the Target Lesion at 12 Month Post Index Procedure.
Primary patency is defined as freedom from target lesion restenosis (TLR) and from binary restenosis. Binary restenosis is adjudicated by the independent Core Laboratory based on Peak Systolic Velocity Ratio (PSVR) ≥ 2.5 and / or abnormal waveforms, or based on angiographic ≥ 50% diameter stenosis.
Measured: 12 months post index procedure
Secondary outcomes (11)
Number of Participants With Freedom From All-cause Perioperative (≤ 30 Day) Death and Freedom From the Following: Index Limb Amputation, Index Limb Re-intervention, and Index-Limb-Related Death.
Measured: 30 days post index procedure
Number of Major Vascular Complications at 30 Days Post Index Procedure
Measured: 30 days
Number of Deaths (All Causes) at 30 Days Post Index Procedure
Measured: 30 days post index procedure
Number of Participants With Clinically Driven Target Lesion Revascularization (TLR) at 1, 6, 12, and 24 Month Post Index Procedure
Measured: 1, 6, 12 and 24 months post index procedure
Number of Participants With Target Vessel Revascularization (TVR) at 1, 6, 12, and 24 Months Post Index Porcedure
Measured: 1, 6, 12 and 24 months post index procedure
Number of Participants With Reintervention for Treatment of Thrombosis of the Target Vessel or Embolization to Its Distal Vasculature at 1, 6, 12, and 24 Months Post Index Procedure
Measured: 1, 6, 12 and 24 months post index procedure
Number of Participants With Unanticipated and Anticipated Device Related Serious Adverse Events at 1, 6, 12, and 24 Months Post Index Procedure
Measured: 1, 6, 12 and 24 months post index procedure
Number of Participants With Amputation (Above the Ankle)-Free Survival (AFS) at 1, 6, 12, and 24 Months Post Index Procedure.
Measured: 1, 6, 12 and 24 months
Change in Rutherford Classification Scores at 1, 6, 12, and 24 Months Post Index Procedure Compared to Baseline
Measured: 1, 6, 12 and 24 months post index procedure
Number of Participants With Sustained Clinical Benefit at 1, 6, 12, and 24 Months Post Index Procedure
Measured: 1, 6, 12 and 24 months post index procedure
Change of Resting Ankle Brachial Index (ABI) Scores at 1, 6, 12, and 24 Months Post Index Procedure Compared to Baseline
Measured: 1, 6, 12 and 24 months post index procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jun 2016 (estimated)
- Study start20 Apr 2018
- Primary completion18 Feb 2019
- Study completion18 Feb 2019
Why it stopped: FDA allowed other data to be leveraged to meet the study requirements
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.
- Other trials for Femoral Artery StenosisStudies of the same condition, open and under way.
- More trials run by C. R. BardThe sponsor's other registered studies.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 4 participants (actual)
Sponsor and investigators
- Lead sponsor
- C. R. Bard
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Christopher Metzger, MD, Principal investigator, Wellmont CVA Heart Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02813577
- Sponsor's protocol ID
- CL0025-01
- Acronym
- CONFIRM
- Status last verified
- Apr 2020
- First submitted
- 16 Jun 2016
- Last updated
- 24 Apr 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Multicenter, Single Arm, Post-Approval Study of the Lutonix Drug Coated Balloon for Treatment of Femoropopliteal Arteries in United States Females
- ClinicalTrials.gov ID
- NCT02813577
- Acronym / sponsor ID
- CONFIRM / CL0025-01
- Conditions
- Femoral Artery Stenosis, Popliteal Artery Stenosis, Femoral Artery Occlusion, Popliteal Artery Occlusion
- Keywords
- Legs, Drug Coated Angioplasty Balloon, Experimental, Standard Angioplasty Balloon
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: FDA allowed other data to be leveraged to meet the study requirements
- Enrolment
- 4 participants (actual)
- Lead sponsor
- C. R. BardIndustry (pharma, biotech, devices)
- Study start
- 20 Apr 2018 (actual)
- Primary completion
- 18 Feb 2019 (actual)
- Study completion
- 18 Feb 2019 (actual)
- First posted
- 27 Jun 2016 (estimated)
- Results
- Posted 24 Apr 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The post approval study will enroll US female patients presenting with claudication or ischemic rest pain and an angiographically significant lesion in the superficial femoral or popliteal artery. Subjects are treated per Instructions For Use (IFU) with the Lutonix® Catheter. Subjects will have a Duplex Ultrasound (DUS) and clinical follow-up through two (2) years.
Detailed description
The Lutonix® 035 Drug Coated Balloon PTA Catheter (Lutonix® Catheter) has been approved by the Food and Drug Administration (P130024) for percutaneous transluminal angioplasty, after appropriate vessel preparation of de novo, restenotic, or in-stent restenotic lesions up to 300 mm in length in native superficial femoral or popliteal arteries with reference vessel diameters of 4-7 mm. The purpose of this post-approval study is to assess the safety and effectiveness of the Lutonix® Catheter in the US female population. This study will enroll approximately 165 female patients at a minimum of 10 US centers and a maximum of 25.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Lutonix® 035 Drug Coated Balloon PTA Catheter | Other | Device: Lutonix® 035 Drug Coated Balloon PTA CatheterThis is a single-arm study. Female subjects will receive the Lutonix® 035 Drug Coated Balloon PTA Catheter. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (0 listed)
Key exclusion criteria (6 listed)
- Life expectancy of <2 years;
- Subject is currently participating in an investigational drug or device study, or previously enrolled in this study. Enrollment in another investigational drug or device study during the follow up period is not allowed;
- History of stroke within 3 months;
- History of myocardial infarction (MI), thrombolysis or angina within 2 weeks of index procedure;
- Renal failure or chronic kidney disease with serum creatinine ≥2.5 mg/L within 30 days of index procedure or treated with dialysis;
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 |
|---|---|---|
| Lutonix® 035 Drug Coated Balloon PTA CatheterFemale subjects will receive the Lutonix® 035 Drug Coated Balloon PTA Catheter. | Device | Lutonix® 035 Drug Coated Balloon PTA Catheter |
Primary outcome
Number of Participants With Freedom From the Following: All-cause Peri-operative Death at 30 Days, Index Limb Amputation Within 1 Year, Index Limb Re-intervention Within 1 Year, and Index-limb-Related Death Within 1 Year Post Index Procedure
Time frame: 12 months post index procedure
Index limb amputation includes above or below the ankle amputations.
Effectiveness: Number of Participants With Primary Patency of the Target Lesion at 12 Month Post Index Procedure.
Time frame: 12 months post index procedure
Primary patency is defined as freedom from target lesion restenosis (TLR) and from binary restenosis. Binary restenosis is adjudicated by the independent Core Laboratory based on Peak Systolic Velocity Ratio (PSVR) ≥ 2.5 and / or abnormal waveforms, or based on angiographic ≥ 50% diameter stenosis.
11 secondary outcomes
Number of Participants With Freedom From All-cause Perioperative (≤ 30 Day) Death and Freedom From the Following: Index Limb Amputation, Index Limb Re-intervention, and Index-Limb-Related Death.
Time frame: 30 days post index procedure
Number of Major Vascular Complications at 30 Days Post Index Procedure
Time frame: 30 days
Number of Deaths (All Causes) at 30 Days Post Index Procedure
Time frame: 30 days post index procedure
Number of Participants With Clinically Driven Target Lesion Revascularization (TLR) at 1, 6, 12, and 24 Month Post Index Procedure
Time frame: 1, 6, 12 and 24 months post index procedure
Number of Participants With Target Vessel Revascularization (TVR) at 1, 6, 12, and 24 Months Post Index Porcedure
Time frame: 1, 6, 12 and 24 months post index procedure
Number of Participants With Reintervention for Treatment of Thrombosis of the Target Vessel or Embolization to Its Distal Vasculature at 1, 6, 12, and 24 Months Post Index Procedure
Time frame: 1, 6, 12 and 24 months post index procedure
Number of Participants With Unanticipated and Anticipated Device Related Serious Adverse Events at 1, 6, 12, and 24 Months Post Index Procedure
Time frame: 1, 6, 12 and 24 months post index procedure
Number of Participants With Amputation (Above the Ankle)-Free Survival (AFS) at 1, 6, 12, and 24 Months Post Index Procedure.
Time frame: 1, 6, 12 and 24 months
Change in Rutherford Classification Scores at 1, 6, 12, and 24 Months Post Index Procedure Compared to Baseline
Time frame: 1, 6, 12 and 24 months post index procedure
Number of Participants With Sustained Clinical Benefit at 1, 6, 12, and 24 Months Post Index Procedure
Time frame: 1, 6, 12 and 24 months post index procedure
Change of Resting Ankle Brachial Index (ABI) Scores at 1, 6, 12, and 24 Months Post Index Procedure Compared to Baseline
Time frame: 1, 6, 12 and 24 months post index procedure
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Apr 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Lutonix® 035 Drug Coated Balloon PTA Catheter Instructions For UseLink 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.
Christopher Metzger, MD principal investigator
Wellmont CVA Heart Institute
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Lutonix® 035 Drug Coated Balloon PTA Catheter in people with Femoral Artery Stenosis and Popliteal Artery Stenosis, run by C. R. Bard at 4 sites in United States.
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 0 inclusion and 6 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: stopped early, as of the sponsor's last update on 24 Apr 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States. 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 24 Apr 2020). 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 Freedom From the Following: All-cause Peri-operative Death at 30 Days, Index Limb Amputation Within 1 Year, Index Limb Re-intervention Within 1 Year, and Index-limb-Related Death Within 1 Year Post Index Procedure (time frame: 12 months post index procedure). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 24 Apr 2020.