Randomized Study of Laser and Balloon Angioplasty Versus Balloon Angioplasty to Treat Peripheral In-stent Restenosis (EXCITE ISR)

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2013 by Spectranetics Corporation
Sponsor:
Information provided by (Responsible Party):
Spectranetics Corporation
ClinicalTrials.gov Identifier:
NCT01330628
First received: April 4, 2011
Last updated: September 23, 2013
Last verified: September 2013
  Purpose

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.


Condition Intervention Phase
Peripheral Arterial Disease
Device: Turbo Elite Laser and Turbo Tandem Laser Guide Catheters
Procedure: Balloon angioplasty
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: EXCImer Laser Randomized Controlled Study for Treatment of FemoropopliTEal In-Stent Restenosis

Resource links provided by NLM:


Further study details as provided by Spectranetics Corporation:

Primary Outcome Measures:
  • Target lesion revascularization (TLR) [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Major Adverse Events [ Time Frame: 30 days ] [ Designated as safety issue: Yes ]
    death, amputation, target lesion revascularization


Secondary Outcome Measures:
  • Procedural success [ Time Frame: (day 1) During the interventional procedure in catheterization laboratory. Procedure may last 1-2 hours. ] [ Designated as safety issue: No ]
    Defined as a ≤30% stenosis in the target lesion immediately post assigned treatment

  • Target vessel revascularization [ Time Frame: 6 and 12 months ] [ Designated as safety issue: No ]
  • Primary patency [ Time Frame: 1, 6, and 12 months ] [ Designated as safety issue: No ]
    The proportion of subjects, with uninterrupted (intervention-free) patency since the initial procedure. Primary patency ends at the first occurrence of one of the following: reintervention for the purpose of treating the target lesion, total occlusion of the target lesion, surgical bypass of the target, or amputation of the extremity due to target lesion restenosis or occlusion.

  • Assisted primary patency [ Time Frame: 1, 6, and 12 months ] [ Designated as safety issue: No ]
    Defined as a re-intervention of a stenosis (patent vessel) >50% at the treatment site to prevent reocclusion by angiographic assessment in the target lesion.

  • Assisted secondary patency [ Time Frame: 1, 6, and 12 months ] [ Designated as safety issue: No ]
    Defined as a re-intervention of a reocclusion (non-patent vessel) at the treatment site by angiographic assessment in the target lesion.

  • Ankle/Brachial Index (ABI) [ Time Frame: 1, 6, and 12 months ] [ Designated as safety issue: No ]
  • Functional status [ Time Frame: 1, 6, and 12 months ] [ Designated as safety issue: No ]
    The Walking Impairment Questionnaire (WIQ) at 30 day follow up will be considered baseline and will be compared to the WIQ at 6 and 12 months.

  • Rutherford classification [ Time Frame: 1, 6, and 12 months ] [ Designated as safety issue: No ]
  • Stent integrity [ Time Frame: 6 and 12 months ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 353
Study Start Date: June 2011
Estimated Study Completion Date: June 2014
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Laser atherectomy and PTA
laser, then balloon angioplasty
Device: Turbo Elite Laser and Turbo Tandem Laser Guide Catheters
application of laser energy to remove blockage followed by standard balloon angioplasty
Active Comparator: Balloon angioplasty Procedure: Balloon angioplasty
standard balloon catheters for PTA

  Eligibility

Ages Eligible for Study:   18 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01330628

Contacts
Contact: Chris DeMorett 719-447-2211 christopher.demorett@spnc.com
Contact: Matthew Stark, PhD 719-447-2409 matthew.stark@spnc.com

  Show 34 Study Locations
Sponsors and Collaborators
Spectranetics Corporation
Investigators
Principal Investigator: Eric J Dippel, MD Genesis Health System
  More Information

No publications provided

Responsible Party: Spectranetics Corporation
ClinicalTrials.gov Identifier: NCT01330628     History of Changes
Other Study ID Numbers: D013474
Study First Received: April 4, 2011
Last Updated: September 23, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Spectranetics Corporation:
peripheral arterial disease
in stent restenosis
peripheral vascular disease

Additional relevant MeSH terms:
Peripheral Arterial Disease
Peripheral Vascular Diseases
Arterial Occlusive Diseases
Arteriosclerosis
Atherosclerosis
Cardiovascular Diseases
Vascular Diseases

ClinicalTrials.gov processed this record on October 23, 2014