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In This Section Texas Health Research & Education Institute

Clinical Trials

Disease or Condition   Cardiology
Title   EXCITE TRIAL (Cardiology)
Description   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.
IRB Number   Pro2935
Inclusion/Notes   INCLUSION:
  • 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.

Angiographic Inclusion:
  • 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.

EXCLUSION:
  • 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.

  • Serum creatinine ≥ 2.5 mg/dL unless dialysis-dependent.

  • 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.
Status   Recruiting
Location   Texas Health Presbyterian Hospital Dallas
Principal Name    Tony S Das MD
Contact Name   Angelia Hannah
Phone   (214) 360-0869

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