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NCT00120406 · ClinicalTrials.gov registry record · NA
Evaluation of the Zilver PTX Drug-Eluting Stent in the Above-the-Knee Femoropopliteal Artery
A NA study, sponsored by Cook Group Incorporated.
- Completed
- Registry status
- NA
- Development phase
- 474
- Enrollment target
NCT00120406: Completed NA study, sponsored by Cook Group Incorporated.
NCT00120406 is a NA study that has completed, run by Cook Group Incorporated. The registered enrollment target is 474 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (66% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00120406, a NA study, has completed, sponsored by Cook Group Incorporated.
- COMPLETED
- Registry status
- NA
- Development phase
- 474 participants
- Enrollment target
Study 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).
Primary Outcome
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. Participant flow is based on initial randomization of Zilver PTX or PTA (Percutaneous balloon angioplasty), and Event-free surv
Interventions
- PROCEDURE Angioplasty
- DEVICE Zilver® PTX™ Drug Eluting Vascular Stent
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 474 participants |
| Start Date | 2005-03 |
| Est. Completion | 2014-02 |
| Phase | NA |
What the finished NCT00120406 record still lists
NCT00120406 is an interventional study that assigns participants to a tested intervention. The registered 474 participants enrollment target is mid-sized for trials with a published cap, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (66% lower).
The record links to 0 conditions, and to 2 interventions - of which Angioplasty is the first listed.
NCT00120406 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00120406 about?
NCT00120406 is a clinical study titled "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 ...
What is the current status of trial NCT00120406?
This trial is currently completed. It is a NA study. The enrollment target is 474 participants. The study started on 2005-03. Estimated completion is 2014-02.
What interventions are being tested in trial NCT00120406?
The interventions under investigation include: Angioplasty (PROCEDURE), Zilver® PTX™ Drug Eluting Vascular Stent (DEVICE).
Who is sponsoring clinical trial NCT00120406?
This trial is sponsored by Cook Group Incorporated, which has 31 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00120406's enrollment target sits among peer trials
474 220th of 2000 higher than 1,781 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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