Clinical trial NCT01330628: Randomized Study of Laser and Balloon Angioplasty Versus Balloon Angioplasty to Treat Peripheral In-stent Restenosis
Official title: EXCImer Laser Randomized Controlled Study for Treatment of FemoropopliTEal In-Stent Restenosis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Peripheral Arterial Disease
Keywords: peripheral arterial disease
in stent restenosis
peripheral vascular disease
Lead sponsor: Spectranetics Corporation
Sponsor class: INDUSTRY
First posted: 2011-04-07
Enrollment: 252
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Freedom From Target Lesion Revascularization (TLR)
timeFrame: 6 months
measure: Freedom From Major Adverse Events (MAE)
timeFrame: 30 days
Secondary outcomes:
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: St. Vincent's East
state: Alabama
city: Fairhope
country: United States
facility: Thomas Hospital
state: Alabama
city: Little Rock
country: United States
facility: St. Vincent Heart Clinic Arkansas
state: Arkansas
city: Little Rock
country: United States
facility: Arkansas Heart Hospital
state: Arkansas
city: Sacramento
country: United States
facility: UC-Davis Medical Centers
state: California
city: New Haven
country: United States
facility: Yale - New Haven Hospital
state: Connecticut
city: Washington, D.C.
country: United States
facility: Washington Hospital Center
state: District of Columbia
city: Gainesville
country: United States
facility: The Cardiac and Vascular Institute
state: Florida
city: Hollywood
country: United States
facility: Memorial Regional Hospital
state: Florida
city: Miami
country: United States
facility: Mount Sinai Medical Center
state: Florida
city: Springfield
country: United States
facility: St. John's Hospital
state: Illinois
city: Munster
country: United States
facility: Community Hospital
state: Indiana
city: Davenport
country: United States
facility: Genesis Health System
state: Iowa
city: Bossier
country: United States
facility: Cardiovascular Consultants
state: Louisiana
city: Lafayette
country: United States
facility: Regional Medical center of Acadiana
state: Louisiana
city: Opelousas
country: United States
facility: Opelousas General Hospital
state: Louisiana
city: Boston
country: United States
facility: Steward - St. Elizabeth's
state: Massachusetts
city: Southfield
country: United States
facility: St. John's - Providence Hospital
state: Michigan
city: Wyoming
country: United States
facility: Metro Health Hospital
state: Michigan
city: Hattiesburg
country: United States
facility: Hattiesburg Clinic
state: Mississippi
city: Browns Mills
country: United States
facility: Deborah Heart and Lung
state: New Jersey
city: New York
country: United States
facility: New York University
state: New York
city: Wilmington
country: United States
facility: Coastal Surgery Specialists
state: North Carolina
city: Bryn Mawr
country: United States
facility: Bryn Mawr
state: Pennsylvania
city: Providence
country: United States
facility: The Miriam Hospital
state: Rhode Island
city: Kingsport
country: United States
facility: Wellmont Holston Valley Medical
state: Tennessee
city: Dallas
country: United States
facility: Presbyterian Hospital of Dallas
state: Texas
city: El Paso
country: United States
facility: El Paso Cardiac and Endovascular Center
state: Texas
city: Tyler
country: United States
facility: Tyler Cardiac and Endovascular Center
state: Texas
city: Waco
country: United States
facility: Providence Health Center
state: Texas
city: Norfolk
country: United States
facility: Sentara Norfolk General Hospital
state: Virginia
city: Milwaukee
country: United States
facility: Wheaton Franciscan Healthcare - All Saints Hospital
state: Wisconsin
city: Milwaukee
country: United States
facility: St. Luke's Medical Center
state: Wisconsin
city: San Juan
country: Puerto Rico
facility: Transcatheter Medical Inc.
Study officials:
affiliation: Genesis Health System
name: Eric J Dippel, MD
role: PRINCIPAL_INVESTIGATOR
References:
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.