Peripheral Arterial DiseasePhase 2/3EXCITE ISRNCT01330628
Randomized Study of Laser and Balloon Angioplasty Versus Balloon Angioplasty to Treat Peripheral In-stent Restenosis
A Phase 2/3 study testing Turbo Elite Laser and Turbo Tandem Laser Guide Catheters and Balloon angioplasty in people with Peripheral Arterial Disease, run by Spectranetics Corporation at 34 sites in 2 countries.
Trial summary
The purpose of the study is to evaluate the safety and efficacy of laser atherectomy with balloon angioplasty compared to balloon angioplasty alone in the treatment of above the knee peripheral artery in-stent restenosis. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Peripheral Arterial Disease
- What is being tested?
- Turbo Elite Laser and Turbo Tandem Laser Guide Catheters and Balloon angioplasty
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 252 participants
- Where
- 34 sitesin 2 countries
- Study dates
- Jun 2011to May 2015
- Phase
- Phase 2/3
- 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 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- PAD with Rutherford class 1-4
- Resting ABI <0.9 or abnormal exercise ABI <0.9
- History of previous femoropopliteal nitinol stenting
- Angiographic significant restenosis (>=50%)
- Target lesion length >=4 cm; no more than 3 cm outside stent at either end
- Vessel diameter >=5 mm and <=7 mm
- At least one widely patent tibial or peroneal artery to the foot
Who cannot join
- Patient is pregnant or breast feeding
- Evidence of acute limb ischemia
- Life expectancy <12 months
- CVA within 60 days of screening
- Myocardial infarction within 60 days of procedure
- Known allergy to contract media
Show all 17Show fewer
- Known contraindication to aspirin, antiplatelet and anti-coagulation therapies
- Uncontrolled hypercoagulability
- Present or suspected systemic infection in target limb
- Serum creatinine >= 2.5 mg/dl unless dialysis dependent
- Previous treatment to target vessel within 3 months of study procedure
- Drug eluting stents or covered stents in target lesion
- Ipsilateral and/or contralateral iliac stenosis >= 50% DS that is not successfully treated prior to index procedure or with final residual stenosis <= 30% documented by angiography
- Planned or predicted cardiovascular surgical or interventional procedures prior to completion of the 30-day follow-up
- Identification of any lesion below the target stent in the treated leg >50% that will require preplanned or predicted treatment within 30 days(prior to the 6 month follow up)
- Tibial artery containing a >50% Diameter Stenosis (DS) by visual estimate after popliteal
- Grade 4 or 5 stent fracture affecting target stent or proximal to the target stent, or where evidence of stent protrusion into the lumen is noted on angiography in 2 orthogonal views.
Trial locations and contacts
34 sites in 2 countries.
34 sites in 2 countries
United States33 sites
St. Vincent's East
Birmingham, Alabama, 35235
Cardiovascular Consultants
Bossier City, Louisiana, 71111
Steward - St. Elizabeth's
Boston, Massachusetts, 02135
Deborah Heart and Lung
Browns Mills, New Jersey, 08015
Bryn Mawr
Bryn Mawr, Pennsylvania, 19010
Presbyterian Hospital of Dallas
Dallas, Texas, 75230
Genesis Health System
Davenport, Iowa, 52803
El Paso Cardiac and Endovascular Center
El Paso, Texas, 79902
Thomas Hospital
Fairhope, Alabama, 36533
The Cardiac and Vascular Institute
Gainesville, Florida, 32605
Hattiesburg Clinic
Hattiesburg, Mississippi, 39401
Memorial Regional Hospital
Hollywood, Florida, 33021
Wellmont Holston Valley Medical
Kingsport, Tennessee, 37660
Regional Medical center of Acadiana
Lafayette, Louisiana, 70506
St. Vincent Heart Clinic Arkansas
Little Rock, Arkansas, 72205
Arkansas Heart Hospital
Little Rock, Arkansas, 72211
Mount Sinai Medical Center
Miami, Florida, 33140
Wheaton Franciscan Healthcare - All Saints Hospital
Milwaukee, Wisconsin, 53212
St. Luke's Medical Center
Milwaukee, Wisconsin, 53215
Community Hospital
Munster, Indiana, 46321
Yale - New Haven Hospital
New Haven, Connecticut, 06510
New York University
New York, New York, 10016
Sentara Norfolk General Hospital
Norfolk, Virginia, 23507
Opelousas General Hospital
Opelousas, Louisiana, 70570
The Miriam Hospital
Providence, Rhode Island, 02904
UC-Davis Medical Centers
Sacramento, California, 95817
St. John's - Providence Hospital
Southfield, Michigan, 48075
St. John's Hospital
Springfield, Illinois, 62874
Tyler Cardiac and Endovascular Center
Tyler, Texas, 75701
Providence Health Center
Waco, Texas, 76712
Washington Hospital Center
Washington D.C., District of Columbia, 20010
Coastal Surgery Specialists
Wilmington, North Carolina, 284001
Metro Health Hospital
Wyoming, Michigan, 49519
About this study
Official title: EXCImer Laser Randomized Controlled Study for Treatment of FemoropopliTEal In-Stent Restenosis
The purpose of the study is to evaluate the safety and efficacy of laser atherectomy with balloon angioplasty compared to balloon angioplasty alone in the treatment of above the knee peripheral artery in-stent restenosis.
- Conditions
- Peripheral Arterial Disease
- Being tested
- Turbo Elite Laser and Turbo Tandem Laser Guide Catheters, Balloon angioplasty
- Keywords
- peripheral arterial disease, in stent restenosis, peripheral vascular disease
- Medical subject headings
- Peripheral Arterial Disease, Peripheral Vascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Turbo Elite Laser and Turbo Tandem Laser Guide CathetersDevice
application of laser energy to remove blockage followed by standard balloon angioplasty
Balloon angioplastyProcedure or surgery
standard balloon catheters for PTA
| Study group | Role | What they receive |
|---|---|---|
| Laser atherectomy and PTA | Experimental | laser, then balloon angioplasty Receives: Device: Turbo Elite Laser and Turbo Tandem Laser Guide Catheters |
| Balloon angioplasty | Active comparator | Not described Receives: Procedure: Balloon angioplasty |
What is being measured
The primary outcome is the main question the study is designed to answer.
Freedom From Target Lesion Revascularization (TLR)
Number of participants free from Target Lesion Revascularization (TLR) through 6 months follow-up.
Measured: 6 months
Freedom From Major Adverse Events (MAE)
Number of participants free from Major Adverse Events (MAE) at 30 days. MAE are defined all cause death, major amputation in the target limb, or target lesion revascularization (TLR) from procedure to 30 days (±7 days).
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Apr 2011 (estimated)
- Study startJun 2011
- Primary completionMar 2014
- Study completionMay 2015
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 (1)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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 252 participants (actual)
Sponsor and investigators
- Lead sponsor
- Spectranetics Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Eric J Dippel, MD, Principal investigator, Genesis Health System
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01330628
- Sponsor's protocol ID
- D013474
- Acronym
- EXCITE ISR
- Status last verified
- Jul 2016
- First submitted
- 4 Apr 2011
- Last updated
- 18 Aug 2016
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Dippel EJ, Makam P, Kovach R, George JC, Patlola R, Metzger DC, Mena-Hurtado C, Beasley R, Soukas P, Colon-Hernandez PJ, Stark MA, Walker C; EXCITE ISR Investigators. Randomized controlled study of excimer laser atherectomy for treatment of femoropopliteal in-stent restenosis: initial results from the EXCITE ISR trial (EXCImer Laser Randomized Controlled Study for Treatment of FemoropopliTEal In-Stent Restenosis). JACC Cardiovasc Interv. 2015 Jan;8(1 Pt A):92-101. doi: 10.1016/j.jcin.2014.09.009. Epub 2014 Dec 10.
PubMed 25499305
Study at a glance
From the registry record, last updated by the sponsor on 18 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- EXCImer Laser Randomized Controlled Study for Treatment of FemoropopliTEal In-Stent Restenosis
- ClinicalTrials.gov ID
- NCT01330628
- Acronym / sponsor ID
- EXCITE ISR / D013474
- Conditions
- Peripheral Arterial Disease
- Keywords
- peripheral arterial disease, in stent restenosis, peripheral vascular disease
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 252 participants (actual)
- Lead sponsor
- Spectranetics CorporationIndustry (pharma, biotech, devices)
- Study start
- Jun 2011
- Primary completion
- Mar 2014 (actual)
- Study completion
- May 2015 (actual)
- First posted
- 7 Apr 2011 (estimated)
- Results
- Posted 15 Jun 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of the study is to evaluate the safety and efficacy of laser atherectomy with balloon angioplasty compared to balloon angioplasty alone in the treatment of above the knee peripheral artery in-stent restenosis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Laser atherectomy and PTA | Experimental | Device: Turbo Elite Laser and Turbo Tandem Laser Guide Catheterslaser, then balloon angioplasty |
| Balloon angioplasty | Active comparator | Procedure: Balloon angioplasty |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- PAD with Rutherford class 1-4
- Resting ABI <0.9 or abnormal exercise ABI <0.9
- History of previous femoropopliteal nitinol stenting
- Angiographic significant restenosis (>=50%)
- Target lesion length >=4 cm; no more than 3 cm outside stent at either end
Key exclusion criteria (17 listed)
- Patient is pregnant or breast feeding
- Evidence of acute limb ischemia
- Life expectancy <12 months
- CVA within 60 days of screening
- Myocardial infarction within 60 days of procedure
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 |
|---|---|---|
| Turbo Elite Laser and Turbo Tandem Laser Guide Cathetersapplication of laser energy to remove blockage followed by standard balloon angioplasty | Device | Laser atherectomy and PTA |
| Balloon angioplastystandard balloon catheters for PTA | Procedure or surgery | Balloon angioplasty |
Primary outcome
Freedom From Target Lesion Revascularization (TLR)
Time frame: 6 months
Number of participants free from Target Lesion Revascularization (TLR) through 6 months follow-up.
Freedom From Major Adverse Events (MAE)
Time frame: 30 days
Number of participants free from Major Adverse Events (MAE) at 30 days. MAE are defined all cause death, major amputation in the target limb, or target lesion revascularization (TLR) from procedure to 30 days (±7 days).
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Aug 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 25499305Dippel EJ, Makam P, Kovach R, George JC, Patlola R, Metzger DC, Mena-Hurtado C, Beasley R, Soukas P, Colon-Hernandez PJ, Stark MA, Walker C; EXCITE ISR Investigators. Randomized controlled study of excimer laser atherectomy for treatment of femoropopliteal in-stent restenosis: initial results from the EXCITE ISR trial (EXCImer Laser Randomized Controlled Study for Treatment of FemoropopliTEal In-Stent Restenosis). JACC Cardiovasc Interv. 2015 Jan;8(1 Pt A):92-101. doi: 10.1016/j.jcin.2014.09.009. Epub 2014 Dec 10.
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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.
Eric J Dippel, MD principal investigator
Genesis Health System
34 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Turbo Elite Laser and Turbo Tandem Laser Guide Catheters and Balloon angioplasty in people with Peripheral Arterial Disease, run by Spectranetics Corporation at 34 sites in 2 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 7 inclusion and 17 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 18 Aug 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 34 sites in United States, Puerto Rico. 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.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 15 Jun 2016). 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?
Freedom From Target Lesion Revascularization (TLR) (time frame: 6 months). 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?
On the ClinicalTrials.gov record for NCT01330628, which also lists 1 linked publication.
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 18 Aug 2016.