Status:
COMPLETED
Drug Eluting Stents In The Critically Ischemic Lower Leg 2
Lead Sponsor:
Flanders Medical Research Program
Conditions:
Peripheral Arterial Disease
Eligibility:
All Genders
18+ years
Phase:
PHASE2
PHASE3
Brief Summary
The objective of this clinical evaluation is to evaluate the immediate and long term (up to 12 months) outcome of the XIENCE PRIME Everolimus Eluting Coronary Stent System (Abbott Vascular) in a contr...
Detailed Description
The aim of this research is to evaluate the immediate and long term outcome of the XIENCE PRIME EverolimusEluting Coronary Stent System in a prospective investigation for the treatment of patients wit...
Eligibility Criteria
Inclusion
- 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
- Patient is eligible for treatment with the XIENCE PRIME stent (Abbott Vascular)
- 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
- De novo lesion or restenotic lesion after PTA in the infrapopliteal arteries, suitable for endovascular therapy
- Total target lesion length minimally 30mm and maximally 100mm
- Target vessel diameter visually estimated to be \>2.0mm and \<3.5mm
- Guidewire and delivery system successfully traversed lesion
Exclusion
- Patient refusing treatment
- 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
- Non-atherosclerotic 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 :
July 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2014
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT01442636
Start Date
July 1 2011
End Date
November 1 2014
Last Update
March 9 2015
Active Locations (6)
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1
Prince of Wales Private Hospital
Randwick, New South Wales, Australia, 2031
2
Imelda Hospital
Bonheiden, Antwerp, Belgium, 2820
3
Department Vascular Surgery, A.Z. Sint-Blasius Hospital
Dendermonde, East-Flanders, Belgium, 9200
4
Herz-zentrum Bad Krozingen
Bad Krozingen, Germany, 79189