Back to resultsRandomized Study of Laser and Balloon Angioplasty Versus Balloon Angioplasty to Treat Peripheral In-stent Restenosis (EXCITE ISR)
Primary Purpose
Peripheral Arterial Disease
Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Turbo Elite Laser and Turbo Tandem Laser Guide Catheters
Balloon angioplasty
Sponsored by
About this trial
This is an interventional treatment trial for Peripheral Arterial Disease focused on measuring peripheral arterial disease, in stent restenosis, peripheral vascular disease
Eligibility Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
- 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.
Sites / Locations
- St. Vincent's East
- Thomas Hospital
- St. Vincent Heart Clinic Arkansas
- Arkansas Heart Hospital
- UC-Davis Medical Centers
- Yale - New Haven Hospital
- Washington Hospital Center
- The Cardiac and Vascular Institute
- Memorial Regional Hospital
- Mount Sinai Medical Center
- St. John's Hospital
- Community Hospital
- Genesis Health System
- Cardiovascular Consultants
- Regional Medical center of Acadiana
- Opelousas General Hospital
- Steward - St. Elizabeth's
- St. John's - Providence Hospital
- Metro Health Hospital
- Hattiesburg Clinic
- Deborah Heart and Lung
- New York University
- Coastal Surgery Specialists
- Bryn Mawr
- The Miriam Hospital
- Wellmont Holston Valley Medical
- Presbyterian Hospital of Dallas
- El Paso Cardiac and Endovascular Center
- Tyler Cardiac and Endovascular Center
- Providence Health Center
- Sentara Norfolk General Hospital
- Wheaton Franciscan Healthcare - All Saints Hospital
- St. Luke's Medical Center
- Transcatheter Medical Inc.
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Laser atherectomy and PTA
Balloon angioplasty
Arm Description
laser, then balloon angioplasty
Outcomes
Primary Outcome Measures
Freedom From Target Lesion Revascularization (TLR)
Number of participants free from Target Lesion Revascularization (TLR) through 6 months follow-up.
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).
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01330628
Brief Title
Randomized Study of Laser and Balloon Angioplasty Versus Balloon Angioplasty to Treat Peripheral In-stent Restenosis
Acronym
EXCITE ISR
Official Title
EXCImer Laser Randomized Controlled Study for Treatment of FemoropopliTEal In-Stent Restenosis
Study Type
Interventional
2. Study Status
Record Verification Date
July 2016
Overall Recruitment Status
Completed
Study Start Date
June 2011 (undefined)
Primary Completion Date
March 2014 (Actual)
Study Completion Date
May 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Spectranetics Corporation
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Peripheral Arterial Disease
Keywords
peripheral arterial disease, in stent restenosis, peripheral vascular disease
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
252 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Laser atherectomy and PTA
Arm Type
Experimental
Arm Description
laser, then balloon angioplasty
Arm Title
Balloon angioplasty
Arm Type
Active Comparator
Intervention Type
Device
Intervention Name(s)
Turbo Elite Laser and Turbo Tandem Laser Guide Catheters
Intervention Description
application of laser energy to remove blockage followed by standard balloon angioplasty
Intervention Type
Procedure
Intervention Name(s)
Balloon angioplasty
Intervention Description
standard balloon catheters for PTA
Primary Outcome Measure Information:
Title
Freedom From Target Lesion Revascularization (TLR)
Description
Number of participants free from Target Lesion Revascularization (TLR) through 6 months follow-up.
Time Frame
6 months
Title
Freedom From Major Adverse Events (MAE)
Description
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).
Time Frame
30 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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
Exclusion Criteria:
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
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Eric J Dippel, MD
Organizational Affiliation
Genesis Health System
Official's Role
Principal Investigator
Facility Information:
Facility Name
St. Vincent's East
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35235
Country
United States
Facility Name
Thomas Hospital
City
Fairhope
State/Province
Alabama
ZIP/Postal Code
36533
Country
United States
Facility Name
St. Vincent Heart Clinic Arkansas
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72205
Country
United States
Facility Name
Arkansas Heart Hospital
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72211
Country
United States
Facility Name
UC-Davis Medical Centers
City
Sacramento
State/Province
California
ZIP/Postal Code
95817
Country
United States
Facility Name
Yale - New Haven Hospital
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06510
Country
United States
Facility Name
Washington Hospital Center
City
Washington, D.C.
State/Province
District of Columbia
ZIP/Postal Code
20010
Country
United States
Facility Name
The Cardiac and Vascular Institute
City
Gainesville
State/Province
Florida
ZIP/Postal Code
32605
Country
United States
Facility Name
Memorial Regional Hospital
City
Hollywood
State/Province
Florida
ZIP/Postal Code
33021
Country
United States
Facility Name
Mount Sinai Medical Center
City
Miami
State/Province
Florida
ZIP/Postal Code
33140
Country
United States
Facility Name
St. John's Hospital
City
Springfield
State/Province
Illinois
ZIP/Postal Code
62874
Country
United States
Facility Name
Community Hospital
City
Munster
State/Province
Indiana
ZIP/Postal Code
46321
Country
United States
Facility Name
Genesis Health System
City
Davenport
State/Province
Iowa
ZIP/Postal Code
52803
Country
United States
Facility Name
Cardiovascular Consultants
City
Bossier
State/Province
Louisiana
ZIP/Postal Code
71111
Country
United States
Facility Name
Regional Medical center of Acadiana
City
Lafayette
State/Province
Louisiana
ZIP/Postal Code
70506
Country
United States
Facility Name
Opelousas General Hospital
City
Opelousas
State/Province
Louisiana
ZIP/Postal Code
70570
Country
United States
Facility Name
Steward - St. Elizabeth's
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02135
Country
United States
Facility Name
St. John's - Providence Hospital
City
Southfield
State/Province
Michigan
ZIP/Postal Code
48075
Country
United States
Facility Name
Metro Health Hospital
City
Wyoming
State/Province
Michigan
ZIP/Postal Code
49519
Country
United States
Facility Name
Hattiesburg Clinic
City
Hattiesburg
State/Province
Mississippi
ZIP/Postal Code
39401
Country
United States
Facility Name
Deborah Heart and Lung
City
Browns Mills
State/Province
New Jersey
ZIP/Postal Code
08015
Country
United States
Facility Name
New York University
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States
Facility Name
Coastal Surgery Specialists
City
Wilmington
State/Province
North Carolina
ZIP/Postal Code
284001
Country
United States
Facility Name
Bryn Mawr
City
Bryn Mawr
State/Province
Pennsylvania
ZIP/Postal Code
19010
Country
United States
Facility Name
The Miriam Hospital
City
Providence
State/Province
Rhode Island
ZIP/Postal Code
02904
Country
United States
Facility Name
Wellmont Holston Valley Medical
City
Kingsport
State/Province
Tennessee
ZIP/Postal Code
37660
Country
United States
Facility Name
Presbyterian Hospital of Dallas
City
Dallas
State/Province
Texas
ZIP/Postal Code
75230
Country
United States
Facility Name
El Paso Cardiac and Endovascular Center
City
El Paso
State/Province
Texas
ZIP/Postal Code
79902
Country
United States
Facility Name
Tyler Cardiac and Endovascular Center
City
Tyler
State/Province
Texas
ZIP/Postal Code
75701
Country
United States
Facility Name
Providence Health Center
City
Waco
State/Province
Texas
ZIP/Postal Code
76712
Country
United States
Facility Name
Sentara Norfolk General Hospital
City
Norfolk
State/Province
Virginia
ZIP/Postal Code
23507
Country
United States
Facility Name
Wheaton Franciscan Healthcare - All Saints Hospital
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53212
Country
United States
Facility Name
St. Luke's Medical Center
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53215
Country
United States
Facility Name
Transcatheter Medical Inc.
City
San Juan
ZIP/Postal Code
00926
Country
Puerto Rico
12. IPD Sharing Statement
Citations:
PubMed Identifier
25499305
Citation
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.
Results Reference
derived
Learn more about this trial
Randomized Study of Laser and Balloon Angioplasty Versus Balloon Angioplasty to Treat Peripheral In-stent Restenosis
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