Peripheral Arterial Disease Clinical Trial
— DESTINY 2Official title:
a Prospective, Multicenter, Controlled Trial Evaluating the Implant of a Drug Eluting Stent (XIENCE PRIME, Abbott Vascular) in the Critically Ischemic Lower Leg
Verified date | March 2015 |
Source | Flanders Medical Research Program |
Contact | n/a |
Is FDA regulated | No |
Health authority | Belgium: Ethics Committee |
Study type | Interventional |
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 controlled prospective investigation for the treatment of patients with critical limb ischemia due to the presence of lesions between 3cm and 10cm in length at the level of the below the knee arteries. Specifically the trial aims to illicit angiographic and ultrasound patency, clinical improvement, and adverse events associated with the use of this stent. The trial design is single armed, prospective, controlled trial run over 12 months of follow-up.
Status | Completed |
Enrollment | 60 |
Est. completion date | November 2014 |
Est. primary completion date | November 2013 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
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 - 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 Inclusion Criteria: - 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 Criteria: - 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. |
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Australia | Prince of Wales Private Hospital | Randwick | New South Wales |
Belgium | Imelda Hospital | Bonheiden | Antwerp |
Belgium | Department Vascular Surgery, A.Z. Sint-Blasius Hospital | Dendermonde | East-Flanders |
Germany | Herz-zentrum Bad Krozingen | Bad Krozingen | |
Germany | Herzzentrum | Leipzig | |
Germany | St Fransiskus hospital | Münster |
Lead Sponsor | Collaborator |
---|---|
Flanders Medical Research Program |
Australia, Belgium, Germany,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Primary patency at 12 months | Absence of restenosis (=50% stenosis) or occlusion within the originally treated lesion based on angiography | 12 months | No |
Secondary | Technical success | The ability to cross and dilate the lesion to achieve residual angiographic stenosis no greater than 30% | procedure | No |
Secondary | Hemodynamic primary patency rate at 1, 6, 12-month follow-up | Patients that present without a hemodynamically significant stenosis at the target area on duplex ultrasound (systolic velocity ratio no greater than 2.4) and without prior TLR are defined as being primary patent at the given follow-up. | 1, 6, 12-month follow-up | No |
Secondary | Limb-salvage rate at all follow-up visits | Absence of major amputation. Major amputation is defined as amputation at or above the ankle, as opposed to minor amputation, being an amputation at or below metatarsal level, preserving functionality of the foot). | 1, 6, 12-month follow-up | No |
Secondary | Primary assisted patency rate at 1, 6, 12-month follow-up | Defined as flow through the treated lesion maintained by repeat percutaneous intervention completed prior to complete vessel closure. | 1, 6, 12-month follow-up | No |
Secondary | Secondary patency rate at 1, 6, 12-month follow-up | Defined as flow through the treated lesion maintained by repeat percutaneous intervention after occlusion of the target lesion. | 1, 6, 12-month follow-up | No |
Secondary | Target lesion revascularization (TLR) at all follow-up visits | A repeat intervention to maintain or re-establish patency within the region of the treated arterial vessel plus 5 mm proximal and distal to the treated lesion edge. | 1, 6, 12-month follow-up | No |
Secondary | Clinical success at all follow-up visits | An improvement of Rutherford classification at 1 day and 1, 6, 12-month follow-up of one class or more as compared to the pre-procedure Rutherford classification. | 1, 6, 12-month | No |
Secondary | Serious adverse events until follow-up completions | Any clinical event that is fatal, life-threatening, or judged to be severe by the investigator; resulted in persistent or significant disability; necessitated surgical or percutaneous intervention; or required prolonged hospitalization. | 1,6,12 months and interim visits | No |
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