Evaluation of the Zilver PTX Drug-Eluting Stent in the Above-the-Knee Femoropopliteal Artery

Completed · Not applicable

Conditions studied: Peripheral Vascular Diseases

In brief

The Zilver® PTX™ Drug Eluting Vascular Stent is indicated for the treatment of symptomatic vascular disease of the above-the-knee femoropopliteal artery (ranging from 4 mm to 9 mm in reference vessel diameter) for lesions up to 7 cm long. The clinical trial is stratified by lesion length. The trial will be conducted in 2 phases, with Phase 1 enrolling patients with lesions less than 7 cm long. Phase 2 of the trial will include longer lesions (up to 14 cm long) and will be initiated upon approval by the Food and Drug Administration (FDA).

Key facts

Study ID

NCT00120406

Run by

Cook Group Incorporated

People needed

474

Starts

2005-03-01

Expected to finish

2014-02-01

Last updated by the study team

2014-08-11

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Patient has signed and dated the informed consent.
• Patient has up to 2 documented stenotic or occluded atherosclerotic lesions (up ro 14 cm long) of the above-the-knee femoropopliteal artery, up to one in each limb, that meet all of the inclusion criteria and none of the exclusion criteria.
• Patient has a de novo or restenotic lesion(s) with >50% stenosis documented angiographically and no prior stent in the target lesion.
• Patient has symptoms of peripheral arterial disease classified as Rutherford Category 2 or greater.
• Patient has a resting Ankle Brachial Index (ABI) <0.9 or an abnormal exercise ABI if resting ABI is normal. Patient with incompressible arteries (ABI >1.2) must have a Toe Brachial Index (TBI) <0.8.
• Patient agrees to return for a clinical status assessment and duplex ultrasound at 6 months, 12 months, and at 2, 3, 4, and 5 years.
• Patient agrees to return for x-rays at 6 and 12 months.
• Patient agrees to return for angiography at 12 months.
• Patient agrees to be contacted by telephone at 1, 3, 9, and 18 months to assess clinical status.

You may not qualify if…

• Patient is pregnant or breast-feeding.
• Patient is simultaneously participating in another investigational drug or device study.
• Patient has significant stenosis or occlusion of inflow tract not successfully treated before this procedure.
• Patient has any planned surgical or interventional procedure within 30 days after the study procedure.
• Patient has had previous stenting of target vessel.
• Patient in whom antiplatelet and/or anticoagulant therapy is contraindicated.
• Patient has known hypersensitivity or contraindication to aspirin, antiplatelet medication, contrast dye, paclitaxel or nitinol and, in the opinion of the investigator, cannot be adequately premedicated.
• Patient lacks at least one patent vessel of runoff with <50% stenosis throughout its course.
• Patient has untreated angiographically-evident thrombus in the target lesion.
• [Additional criteria may apply.]

Where it is running

• Tri-City Medical Center — Oceanside, California, United States
• Stanford University Hospital and Clinics — Stanford, California, United States
• Washington Hospital Center — Washington D.C., District of Columbia, United States
• JFK Memorial Center — Atlantis, Florida, United States
• University of Florida — Gainesville, Florida, United States
• Memorial -- Jacksonville — Jacksonville, Florida, United States
• Baptist Cardiac & Vascular Institute — Miami, Florida, United States
• Orlando Regional Medical Center — Orlando, Florida, United States
• Piedmont Hospital — Atlanta, Georgia, United States
• OSF St. Francis Medical Center — Peoria, Illinois, United States
• Prairie Heart — Springfield, Illinois, United States
• St. Vincent Hospital — Indianapolis, Indiana, United States
• The Care Group — Indianapolis, Indiana, United States
• Christus St. Patrick Hospital — Lake Charles, Louisiana, United States
• Ochsner Clinic Foundation — New Orleans, Louisiana, United States
• Bayview Medical Center — Baltimore, Maryland, United States
• Massachusetts General Hospital — Boston, Massachusetts, United States
• Beth Israel Deaconess Medical Center — Boston, Massachusetts, United States
• Michigan Vascular Research Center — Flint, Michigan, United States
• William Beaumont — Royal Oak, Michigan, United States
• Mayo Clinic — Rochester, Minnesota, United States
• St. Luke's Hospital Kansas — Kansas City, Missouri, United States
• NYU Medical Center — New York, New York, United States
• St. Luke's Roosevelt Hospital Center — New York, New York, United States
• El Camino Hospital — Mountain View, California, United States

Full record on ClinicalTrials.gov

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