N/A
N=474
Evaluation of the Zilver PTX Drug-Eluting Stent in the Above-the-Knee Femoropopliteal Artery
Peripheral Vascular Diseases
Bottom Line
View on ClinicalTrials.gov: NCT00120406 ↗Enrolled (actual)
474
Serious AEs
12.3%
Results posted
Aug 2014
Primary outcome: Primary: Event-free Survival Rate — 90.4; 83.9 Percentage of participants — p=<0.01
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Zilver® PTX™ Drug Eluting Vascular Stent (Device); Angioplasty (Procedure)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Cook Group Incorporated
- Primary completion
- Oct 2009
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Event-free Survival Rate |
90.4; 83.9 | <0.01 sig |
| PRIMARY Primary Patency |
82.7; 32.7 | <0.01 sig |
Summary
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).
Eligibility Criteria
Inclusion Criteria
- 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) 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.
Exclusion Criteria
- 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.]
Data sourced from ClinicalTrials.gov (NCT00120406). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.