Status:
COMPLETED
PREVENT: Promus BTK
Lead Sponsor:
Flanders Medical Research Program
Conditions:
Peripheral Arterial Disease
Eligibility:
All Genders
18+ years
Phase:
PHASE2
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...
Eligibility Criteria
Inclusion
- General
- 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
- 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
- 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.
Key Trial Info
Start Date :
August 1 2012
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 1 2016
Estimated Enrollment :
70 Patients enrolled
Trial Details
Trial ID
NCT01500070
Start Date
August 1 2012
End Date
January 1 2016
Last Update
August 11 2016
Active Locations (8)
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1
Imelda Hospital
Bonheiden, Antwerpen, Belgium, 2820
2
OLV Aalst
Aalst, Oost-Vlaanderen, Belgium, 9300
3
AZ Sint-Blasius
Dendermonde, Oost-Vlaanderen, Belgium, 9200
4
RZ Heilig Hart Tienen
Tienen, Belgium, 3300