Randomized Study of Laser and Balloon Angioplasty Versus Balloon Angioplasty to Treat Peripheral In-stent Restenosis
EXCITE ISR
EXCImer Laser Randomized Controlled Study for Treatment of FemoropopliTEal In-Stent Restenosis
1 other identifier
interventional
252
2 countries
34
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Jun 2011
Typical duration for phase_2
34 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 4, 2011
CompletedFirst Posted
Study publicly available on registry
April 7, 2011
CompletedStudy Start
First participant enrolled
June 1, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2015
CompletedResults Posted
Study results publicly available
June 15, 2016
CompletedAugust 18, 2016
July 1, 2016
2.8 years
April 4, 2011
May 4, 2016
July 19, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Freedom From Target Lesion Revascularization (TLR)
Number of participants free from Target Lesion Revascularization (TLR) through 6 months follow-up.
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).
30 days
Study Arms (2)
Laser atherectomy and PTA
EXPERIMENTALlaser, then balloon angioplasty
Balloon angioplasty
ACTIVE COMPARATORInterventions
application of laser energy to remove blockage followed by standard balloon angioplasty
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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)
- +2 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (34)
St. Vincent's East
Birmingham, Alabama, 35235, United States
Thomas Hospital
Fairhope, Alabama, 36533, United States
St. Vincent Heart Clinic Arkansas
Little Rock, Arkansas, 72205, United States
Arkansas Heart Hospital
Little Rock, Arkansas, 72211, United States
UC-Davis Medical Centers
Sacramento, California, 95817, United States
Yale - New Haven Hospital
New Haven, Connecticut, 06510, United States
Washington Hospital Center
Washington D.C., District of Columbia, 20010, United States
The Cardiac and Vascular Institute
Gainesville, Florida, 32605, United States
Memorial Regional Hospital
Hollywood, Florida, 33021, United States
Mount Sinai Medical Center
Miami, Florida, 33140, United States
St. John's Hospital
Springfield, Illinois, 62874, United States
Community Hospital
Munster, Indiana, 46321, United States
Genesis Health System
Davenport, Iowa, 52803, United States
Cardiovascular Consultants
Bossier City, Louisiana, 71111, United States
Regional Medical center of Acadiana
Lafayette, Louisiana, 70506, United States
Opelousas General Hospital
Opelousas, Louisiana, 70570, United States
Steward - St. Elizabeth's
Boston, Massachusetts, 02135, United States
St. John's - Providence Hospital
Southfield, Michigan, 48075, United States
Metro Health Hospital
Wyoming, Michigan, 49519, United States
Hattiesburg Clinic
Hattiesburg, Mississippi, 39401, United States
Deborah Heart and Lung
Browns Mills, New Jersey, 08015, United States
New York University
New York, New York, 10016, United States
Coastal Surgery Specialists
Wilmington, North Carolina, 284001, United States
Bryn Mawr
Bryn Mawr, Pennsylvania, 19010, United States
The Miriam Hospital
Providence, Rhode Island, 02904, United States
Wellmont Holston Valley Medical
Kingsport, Tennessee, 37660, United States
Presbyterian Hospital of Dallas
Dallas, Texas, 75230, United States
El Paso Cardiac and Endovascular Center
El Paso, Texas, 79902, United States
Tyler Cardiac and Endovascular Center
Tyler, Texas, 75701, United States
Providence Health Center
Waco, Texas, 76712, United States
Sentara Norfolk General Hospital
Norfolk, Virginia, 23507, United States
Wheaton Franciscan Healthcare - All Saints Hospital
Milwaukee, Wisconsin, 53212, United States
St. Luke's Medical Center
Milwaukee, Wisconsin, 53215, United States
Transcatheter Medical Inc.
San Juan, 00926, Puerto Rico
Related Publications (1)
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.
PMID: 25499305DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Amanda Johnson, VP of Regulatory & Medical Affairs
- Organization
- Spectranetics
Study Officials
- PRINCIPAL INVESTIGATOR
Eric J Dippel, MD
Genesis Health System
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- LTE60
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 4, 2011
First Posted
April 7, 2011
Study Start
June 1, 2011
Primary Completion
March 1, 2014
Study Completion
May 1, 2015
Last Updated
August 18, 2016
Results First Posted
June 15, 2016
Record last verified: 2016-07