Safety and Effectiveness of the Peripheral Balloon-Expandable Covered Stent System for Iliac Artery Stenosis/Occlusion. (SELECT)
Recruiting
N/A
Interventional Study
Peripheral Artery Disease (PAD)
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
At a Glance
- Age
- 18 – 80
- Sex
- Any
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 130 (estimated)
- Sponsor
- Zhejiang Zylox Medical Device Co., Ltd. · Industry
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About This Trial
This is a prospective, multi-center, single-arm clinical trial to evaluate the Peripheral Balloon-Expandable Covered Stent System for treating stenosis and/or occlusion in the common and external iliac arteries. The safety and effectiveness of the stent system will be compared to pre-set performance goals. All treated subjects will have follow-up visits at discharge, and at 1, 6, 12, 24, and 36 mo…
Trial Locations
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Eligibility Criteria
Inclusion Criteria:
* Participants aged 18 to 80 years, regardless of sex;
* Participants diagnosed with atherosclerotic disease of the common iliac or external iliac artery;
* Participants with a Rutherford classification of 2 to 4 for the target limb;
* Participants or their legal representatives…
Contacts