PREVENT: a Prospective, Multi-center, Monitored Trial Investigating the Implant of the Promus Everolimus-Eluting Stent System in Critically Ischemic Lesions BTK

Flanders Medical Research Program8 sites in 3 countries70 target enrollmentAugust 2012

ConditionsPeripheral Arterial Disease

Overview

Phase: Phase 2
Intervention: Not specified
Conditions: Peripheral Arterial Disease
Sponsor: Flanders Medical Research Program
Enrollment: 70
Locations: 8
Primary Endpoint: Primary patency
Status: Completed
Last Updated: 9 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

This is a single-arm, prospective, multi-center monitored trial recruiting patients with critical limb ischemia and with one or more lesions in the arteries below the knee. The immediate and long-term (up to 12 months) outcome of the PROMUS ELEMENT Everolimus-Eluting Stent System (Boston Scientific) and the PROMUS ELEMENT PLUS Everolimus-Eluting Stent System (Boston Scientific) will be evaluated.

In 2 Belgian centers, 3 German centers and 1 New Zealand center a total of 70 patients will be recruited. Primary endpoint is primary patency at 12 months, defined as absence of restenosis (≥50% stenosis) or occlusion within the originally treated lesion based on angiography.

Registry

clinicaltrials.gov

Start Date

August 2012

End Date

January 2016

Last Updated

9 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Flanders Medical Research Program

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Patient presenting with rest pain or minor tissue loss (Rutherford class 4 or 5)
•Patient is willing to comply with specified follow-up evaluations at the specified times
•Patient is \>18 years old
•Patient understands the nature of the procedure and provides written informed consent, prior to enrolment in the study
•Patient has a projected life-expectancy of at least 12 months
•The treating physician consider the patient eligible for below-the-knee treatment with the PROMUS ELEMENT Stent (Boston Scientific) and PROMUS ELEMENT PLUS Stent (Boston Scientific)
•Male, infertile female, or female of child bearing potential practicing an acceptable method of birth control with a negative pregnancy test within 7 days prior to study procedure
•Angiographic Inclusion Criteria:
•Single or multiple lesions with minimally 70% stenosis in one or more infrapopliteal arteries, including the tibiofibular trunk
•A maximum of two focal target lesions in one or more infrapopliteal vessels

Exclusion Criteria

•Patient refusing treatment
•Previously implanted stent in the artery to be treated
•Failed PTA of target lesion/vessel less than 3 months prior to study procedure
•The reference segment diameter is not suitable for the available stent design
•Untreated flow-limiting inflow lesions
•Perioperative unsuccessful ipsilateral percutaneous vascular procedure to treat inflow disease just prior to enrollment
•Any previous surgery in the target vessel (including prior ipsilateral crural bypass)
•Aneurysm in the target vessel
•Patient presents with renal failure, evidenced by a serum creatinine level \>2.0mg/dL
•Patient presents with platelet levels above or below normal range

Outcomes

Primary Outcomes

Primary patency

Time Frame: 12 months

Absence of restenosis (50% stenosis) or occlusion within the originally treated lesion based on angiography.

Secondary Outcomes

Technical success(1 day post-procedure)
Secondary patency rate(1, 6 and 12 month follow-up)
Primary assisted patency rate(1, 6 and 12 month follow-up)
Clinical success at follow-up(1 day, 1 month, 6 month and 12 month follow-up)
Improvement of ankle-brachial index (ABI)(1 day, 1 month, 6 month and 12 month follow-up)
Serious Adverse Events (SAE)(1 day, 1 month, 6 month and 12 month follow-up)
Hemodynamic primary patency rate(1, 6 and 12 month follow-up)
Limb-salvage(1, 6 and 12 month follow-up)
Target lesion revascularization (TLR)(1 day, 1 month, 6 month and 12 month follow-up)