Clinical trial NCT01500070: PREVENT: Promus BTK
Official title: PREVENT: a Prospective, Multi-center, Monitored Trial Investigating the Implant of the Promus Everolimus-Eluting Stent System in Critically Ischemic Lesions BTK
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Peripheral Arterial Disease
Keywords: Peripheral Arterial Disease
Claudication
Drug-Eluting Stent
BTK
Everolimus
CLI
Lead sponsor: Flanders Medical Research Program
Sponsor class: NETWORK
First posted: 2011-12-26
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility criteria: General 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
* 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

General 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.

Primary outcomes:
measure: Primary patency
timeFrame: 12 months
Secondary outcomes:
measure: Technical success
timeFrame: 1 day post-procedure
measure: Hemodynamic primary patency rate
timeFrame: 1, 6 and 12 month follow-up
measure: Limb-salvage
timeFrame: 1, 6 and 12 month follow-up
measure: Primary assisted patency rate
timeFrame: 1, 6 and 12 month follow-up
measure: Secondary patency rate
timeFrame: 1, 6 and 12 month follow-up
measure: Target lesion revascularization (TLR)
timeFrame: 1 day, 1 month, 6 month and 12 month follow-up
measure: Clinical success at follow-up
timeFrame: 1 day, 1 month, 6 month and 12 month follow-up
measure: Improvement of ankle-brachial index (ABI)
timeFrame: 1 day, 1 month, 6 month and 12 month follow-up
measure: Serious Adverse Events (SAE)
timeFrame: 1 day, 1 month, 6 month and 12 month follow-up
Other outcomes:
Locations:
city: Bonheiden
country: Belgium
facility: Imelda Hospital
state: Antwerpen
city: Aalst
country: Belgium
facility: OLV Aalst
state: Oost-Vlaanderen
city: Dendermonde
country: Belgium
facility: AZ Sint-Blasius
state: Oost-Vlaanderen
city: Tienen
country: Belgium
facility: RZ Heilig Hart Tienen
city: Leipzig
country: Germany
facility: Herzzentrum Leipzig
state: Freistaat Sachsen
city: Bad-Krözingen
country: Germany
facility: Herzzentrum Bad-Krözingen
state: Land Baden-Württemberg
city: Münster
country: Germany
facility: St. Fransiskus Hospital
state: Nordrhein-Westfalen
city: Auckland City
country: New Zealand
facility: Auckland City Hospital
state: Auckland
Study officials:
affiliation: AZ Sint Blasius, Dendermonde, Belgium
name: Marc Bosiers, MD
role: PRINCIPAL_INVESTIGATOR
References: