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Trial record 1 of 9 for:    EXCITE ISR
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Randomized Study of Laser and Balloon Angioplasty Versus Balloon Angioplasty to Treat Peripheral In-stent Restenosis (EXCITE ISR)

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ClinicalTrials.gov Identifier: NCT01330628
Recruitment Status : Completed
First Posted : April 7, 2011
Results First Posted : June 15, 2016
Last Update Posted : August 18, 2016
Information provided by (Responsible Party):
Spectranetics Corporation

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.

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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 252 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: EXCImer Laser Randomized Controlled Study for Treatment of FemoropopliTEal In-Stent Restenosis
Study Start Date : June 2011
Actual Primary Completion Date : March 2014
Actual Study Completion Date : May 2015

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. Freedom From Target Lesion Revascularization (TLR) [ Time Frame: 6 months ]
    Number of participants free from Target Lesion Revascularization (TLR) through 6 months follow-up.

  2. 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).

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01330628

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Sponsors and Collaborators
Spectranetics Corporation
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Principal Investigator: Eric J Dippel, MD Genesis Health System
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Spectranetics Corporation
ClinicalTrials.gov Identifier: NCT01330628    
Other Study ID Numbers: D013474
First Posted: April 7, 2011    Key Record Dates
Results First Posted: June 15, 2016
Last Update Posted: August 18, 2016
Last Verified: July 2016
Keywords provided by Spectranetics Corporation:
peripheral arterial disease
in stent restenosis
peripheral vascular disease
Additional relevant MeSH terms:
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Peripheral Arterial Disease
Peripheral Vascular Diseases
Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases