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

This study has been completed.
Information provided by (Responsible Party):
Spectranetics Corporation Identifier:
First received: April 4, 2011
Last updated: July 19, 2016
Last verified: July 2016
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
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

Resource links provided by NLM:

Further study details as provided by Spectranetics Corporation:

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

  • 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).

Enrollment: 252
Study Start Date: June 2011
Study Completion Date: May 2015
Primary Completion Date: March 2014 (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


Ages Eligible for Study:   18 Years to 85 Years   (Adult, Senior)
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.
  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 identifier: NCT01330628

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

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Spectranetics Corporation Identifier: NCT01330628     History of Changes
Other Study ID Numbers: D013474
Study First Received: April 4, 2011
Results First Received: May 4, 2016
Last Updated: July 19, 2016

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
Vascular Diseases
Cardiovascular Diseases processed this record on September 21, 2017