Ignite Creation Date:
2024-05-05 @ 11:47 AM
Last Modification Date:
2024-10-26 @ 9:12 AM
Study NCT ID:
NCT00120406
Status:
COMPLETED
Last Update Posted:
2014-08-11
First Post:
2005-07-11
Brief Title:
Evaluation of the Zilver PTX Drug-Eluting Stent in the Above-the-Knee Femoropopliteal Artery
Sponsor:
Cook Group Incorporated
Organization:
Cook Group Incorporated
Study Overview
Official Title:
Evaluation of the Zilver PTX Drug-Eluting Stent in the Above-the-Knee Femoropopliteal Artery
Status:
COMPLETED
Status Verified Date:
2014-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
Zilver PTX
Brief 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
Detailed Description:
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 eg 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
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 eg 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| PS2 | None | None | None |