Peripheral Vascular Diseases Clinical Trial
Official title:
Evaluation of the Zilver PTX Drug-Eluting Stent in the Above-the-Knee Femoropopliteal Artery
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).
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 above-the-knee femoropopliteal
artery is defined as the superficial femoral artery (SFA) and the region of the popliteal
artery above the plane of the femoral epicondyles. 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 FDA.
This study will include 480 patients who will receive the Zilver PTX stent or Percutaneous
transluminal angioplasty (PTA) at up to 100 investigational sites. Clinical data will be
captured on paper and electronic case report forms. Analyses will include evaluation of the
composite event-free survival rate and the patency rate at 6- and 12-month follow-up.
Event-free survival is defined as freedom from the major adverse events of death, target
lesion revascularization, target limb ischemia requiring surgical intervention (bypass or
amputation of toe, foot or leg), surgical repair of the target vessel (e.g., dissection
requiring surgery), and from worsening of the Rutherford classification by 2 classes or to
class 5 or 6. Patency will be assessed by duplex ultrasound in all patients. Patients may be
randomized to one or more of the following sub-studies: IVUS and angiography at 6 months
(stent patients only), angiography at 12 months, pharmacokinetic substudy (Zilver PTX
patients only), or ultrasound (PTA patients only). The trial also includes provisions for
patients experiencing PTA failure. These patients may be randomized to receive a Zilver PTX
stent or a bare Zilver stent.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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