Randomized Study of Laser and Balloon Angioplasty Versus Balloon Angioplasty to Treat Peripheral In-stent Restenosis



Status:Completed
Conditions:Peripheral Vascular Disease
Therapuetic Areas:Cardiology / Vascular Diseases
Healthy:No
Age Range:18 - 85
Updated:2/8/2015
Start Date:June 2011
End Date:June 2014
Contact:Chris DeMorett
Email:christopher.demorett@spnc.com
Phone:719-447-2211

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EXCImer Laser Randomized Controlled Study for Treatment of FemoropopliTEal In-Stent Restenosis

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.


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.
We found this trial at
33
sites
5900 Byron Center Ave SW
Wyoming, Michigan 49519
(616) 252-7200
Metro Health Hospital Metro Health is an integrated healthcare system offering expert, award-winning care that
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Wyoming, MI
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Birmingham, Alabama 35235
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Birmingham, AL
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Bossier, Louisiana 71111
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Bossier, LA
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Boston, Massachusetts 02135
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Boston, MA
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Browns Mills, New Jersey 08015
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Browns Mills, NJ
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77 Morris Avenue
Bryn Mawr, Pennsylvania 19010
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Bryn Mawr, PA
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Dallas, Texas 75231
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Dallas, TX
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Davenport, Iowa 52803
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Davenport, IA
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El Paso, TX
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Fairhope, Alabama 36532
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Fairhope, AL
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Gainesville, Florida 32605
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Gainesville, FL
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Hattiesburg, Mississippi 39401
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Hattiesburg, MS
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Hollywood, Florida 33021
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Hollywood, FL
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Kingsport, Tennessee 37660
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Kingsport, TN
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Lafayette, Louisiana 70506
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Little Rock, Arkansas 72211
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Little Rock, AR
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Little Rock, Arkansas 72205
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Miami, Florida 33140
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Milwaukee, Wisconsin 53215
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Munster, Indiana 46321
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20 York St, N20 York St,
New Haven, Connecticut 06520
(203) 688-4242
Yale-New Haven Hospital Relying on the skill and expertise of more than 4,500 university and...
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70 Washington Square S
New York, New York 10012
(212) 998-1212
New York University More than 175 years ago, Albert Gallatin, the distinguished statesman who served...
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600 Gresham Dr
Norfolk, Virginia 23507
(757) 388-3000
Sentara Norfolk General Hospital Sentara Norfolk General Hospital is recognized as the number one ranked...
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Opelousas, Louisiana 70570
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164 Summit Ave
Providence, Rhode Island 02906
(401) 793-2500
Miriam Hospital The Miriam Hospital is a private, not-for-profit hospital, with a history of providing...
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Sacramento, California 95817
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Southfield, Michigan 48075
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Springfield, Illinois 62701
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Tyler, TX
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Waco, Texas 76712
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Washington, D.C., District of Columbia 20010
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Wilmington, North Carolina 28401
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