In This SectionTexas Health Research & Education Institute
Disease or Condition
EXCITE TRIAL (Cardiology)
The Spectranetics laser catheters used in this study are known as the Turbo Elite and Turbo-Tandem and balloon catheters which are cleared by the FDA to treat peripheral arterial disease in the femoral popliteal arteries.
Age ≥ 18 years and ≤ 85 years.
Subject agrees to participate and comply with the follow up visit and testing requirements and has signed an IRB approved consent form.
Pheripheral arterial disease with Rutherford Class 1-4 documented within 30 days of enrollment.
The subject is able to walk unassisted or with a non-motorized assistive device.
The patient has a resting Ankle-Brachial- Index (ABI) of < 0.9 or an abnormal ABI (<0.9) if resting ABI is normal. Patent with incompressible arteries (ABI) > 1.2) must have a TBI <0.7 in target limb.
History of previous femoropopliteal nitinol stenting which is suspect for in-stent restenosis.
Target lesion access must use the femoral approach that will accommodate at least a 7Fr. sheath.
Angiographic evidence of significant restenosis (≥ 50% by visual estimate) within a previously deployed femoropopliteal bare nitinol stent(s)
Total target treatment length of in-stent restenosis must be ≥ 4.0 cm in length and may include a single or multifocal lesion within the femoropopliteal segments. ( This included the proximal, mid, and / or distal SFA and P1, P2, and/ or P3 segment of the popliteal artery). Edge restenosis may be treated provided the lession is contiguous, contains at least a 1 cm intra-stent component and projects no more than 1 cm outside the margin of the stent (extra-stent).
The femoropopliteal Reference Vessel Diameter (RVD) must be ≥ 5.0 mm and ≤ 7.0 mm, as determined by the operator angiographic assessment of the most normally appearing vessel segment within 10 mm proximately and 10 mm distal to the target segment.
Visible SFA entry atump containing a < 50% Diameter Stenosis(DS) by visual estimate. At least one(1) widely patent tibial artery to the foot ( with no more than 50% at any point) in continuity with the native femoropopliteal artery.
Patient is pregnanat or breast feeding ( Female subjecs childbearing potential must have negative serum pregnancy test 7 days prior to treatment)
Evidence of Acute Limb Ischemia within the past 7 days.
Life expectancy < 12 months.
CVA within < 60 days prior to screening or any CVA with an unresolved walking impairment.
Myocardial infarction < 60 days prior to procedure.
Known contraindication to aspirin, antiplatelet/ anti-coagulant therapies required for the procedure/ follow up.
Known allergy to contrast media that cannot adequately be pre-medicated prior to study procedure.
Uncontrolled hypercoagulability or history of HIT or HITTS syndrome.
Present or suspected systemic infection or osteomyelitis in the target limb.
Simultaneous enrollment in another investigational device or drug study.
Previous treatment to the target vessel within 3 months of the study procedure.
History of previous femoropopliteal stenting in the target vessel with drug eluting stents or covered stents (endografts).
Angiographic Exclusion Criteria:
Ipsilateral and/or contralateral iliac stenosis ≥ 50% DS that is not successfully treated prior to index procedure (e.g. where a perforation occurred requiring a covered stent) 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 (including, but not limited to aortic, renal, cardiac,carotid, contralateral femoropopliteal, and contralateral below the knee).
Identification of any lesion above or below the target stent in the treated leg > 50% that will require preplanned or predicted treatment within 6 months( prior to the 6 month follow up).
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.