PREVENT: Promus BTK

NCT ID: NCT01500070

Last Updated: 2016-08-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 70 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-08-31
• Study Completion Date: 2016-01-31

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.

Conditions

Peripheral Arterial Disease

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Drug-eluting stent

Patients implanted with the PROMUS ELEMENT Everolimus-Eluting Stent System (Boston Scientific) or the PROMUS ELEMENT PLUS Everolimus-Eluting Stent System (Boston Scientific).

Group Type: EXPERIMENTAL

Everolimus-Eluting Stent (PROMUS ELEMENT)

Intervention Type: DEVICE

PROMUS ELEMENT Everolimus-Eluting Stent System (Boston Scientific) or PROMUS ELEMENT PLUS Everolimus-Eluting Stent System (Boston Scientific).

Interventions

Everolimus-Eluting Stent (PROMUS ELEMENT)

PROMUS ELEMENT Everolimus-Eluting Stent System (Boston Scientific) or PROMUS ELEMENT PLUS Everolimus-Eluting Stent System (Boston Scientific).

Intervention Type: DEVICE

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

• 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
• Length of lesion is maximally 40 mm, allowing maximally 2 planned stents to be implanted
• Target vessel diameter visually estimated to be >2.5mm and <4.0mm
• Guidewire and delivery system successfully traversed lesion

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
• Non-atherosclerothic disease resulting in occlusion (e.g. embolism, Buerger's disease, vasculitis)
• Severe medical comorbidities (untreated CAD/CHF, severe COPD, metastatic malignancy, dementia, etc) or other medical condition that would preclude compliance with the study protocol or 1-year life expectancy
• Major distal amputation (above the transmetatarsal) in the study limb or non-study limb
• Septicemia or bacteremia
• Any previously known coagulation disorder, including hypercoagulability
• Contraindication to anticoagulation or antiplatelet therapy
• Known allergies to stent or stent components
• Known allergy to contrast media that cannot be adequately pre-medicated prior to the study procedure
• Patient with known hypersensitivity to heparin, including those patients who have had a previous incidence of heparin-induced thrombocytopenia (HIT) type II
• Currently participating in another clinical research trial
• Angiographic evidence of intra-arterial thrombus or atheroembolism from inflow treatment
• Target lesion access not performed by transfemoral approach.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Flanders Medical Research Program

NETWORK

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Marc Bosiers, MD

Role: PRINCIPAL_INVESTIGATOR

AZ Sint Blasius, Dendermonde, Belgium

Locations

Imelda Hospital

Bonheiden, Antwerpen, Belgium

OLV Aalst

Aalst, Oost-Vlaanderen, Belgium

AZ Sint-Blasius

Dendermonde, Oost-Vlaanderen, Belgium

RZ Heilig Hart Tienen

Tienen, , Belgium

Herzzentrum Bad-Krözingen

Bad-Krözingen, Land Baden-Württemberg, Germany

St. Fransiskus Hospital

Münster, North Rhine-Westphalia, Germany

Herzzentrum Leipzig

Leipzig, Saxony, Germany

Auckland City Hospital

Auckland, Auckland, New Zealand

Countries

Belgium; Germany; New Zealand

Other Identifiers

FMRP-101020

Identifier Type: -

Identifier Source: org_study_id