Drug Eluting Stents In The Critically Ischemic Lower Leg (DESTINY)
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The Destiny trial compares the use of bare metal stent systems with drug eluting stent systems in the treatment of infrapopliteal lesions in patients with Critical Limb Ischemia. It will be investigated whether there is a difference in 12 month angiographic patency of the stented area using the 2 different stent systems.
Condition or disease
Peripheral Vascular DiseaseCritical Limb Ischemia
Device: XIENCE V everolimus eluting coronary stent systemDevice: MULTILINK VISION coronary stent system
The DESTINY Trial: a Prospective Randomized Multicenter Trial Comparing the Implant of a Drug Eluting Stent (XIENCE V, Abbott Vascular) vs. a Bare Metal Stent (MULTILINK VISION, Abbott Vascular) in the Critically Ischemic Lower Leg
Angiographic patency, defined as angiographic binary in-stent restenosis rate (>50% stenosis). [ Time Frame: one year ]
Secondary Outcome Measures :
Technical success defined as the ability to cross and dilate the lesion to achieve residual angiographic stenosis no greater than 30% and residual stenosis less than 50% by duplex ultrasound (US) imaging. [ Time Frame: procedure ]
Primary patency rate at each follow-up. Patients that did not receive any BTK-reintervention and do not exhibit significant restenosis on duplex (PVR ≥ 2.4) are defined as being primary patent at the given follow-up. [ Time Frame: one year ]
Limb-salvage rate (LSR) defined as 1 minus major amputation rate (major amputation is defined as at or above ankle, as opposed to minor amputation being at or below metatarsus preserving functionality of foot). [ Time Frame: one year ]
Clinical events defined as 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. [ Time Frame: one year ]
Clinical success defined as an improvement of Rutherford classification of one class or more as compared to the pre-procedure Rutherford classification. [ Time Frame: one year ]
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Ages Eligible for Study:
18 Years and older (Adult, Older Adult)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
Stenotic (> 50%) or occlusive atherosclerotic disease of the infrapopliteal arteries
A maximum of two focal target lesions in one or more infrapopliteal vessels
Length of lesion is maximally 40 mm, allowing maximally 2 stents to be implanted
Untreatable lesion located at the distal outflow arteries
More than two infrapopliteal lesions in the same limb
Previously implanted stent(s) or PTA at the same lesion site
Lesion location requiring kissing stent procedure
Lesion lies within or adjacent to an aneurysm
Inflow-limiting arterial lesions left untreated
The patient has a known allergy to heparin, Aspirin or other anticoagulant/anti-platelet therapies or a bleeding diatheses or is unable, or unwilling, to tolerate such therapies.
The patient takes Phenprocoumon (Marcumar).
The patient has a history of prior life-threatening contrast media reaction.
The patient is currently enrolled in another investigational device or drug trial.
The patient is currently breast-feeding, pregnant or intends to become pregnant.
The patient is mentally ill or retarded.
Subject has received a heart transplant or any other organ transplant or is on a waiting list for any organ transplant
Subject is receiving or scheduled to receive anticancer therapy for malignancy within 30 days prior to or after the procedure
Subject is receiving immunosuppression therapy, or has known serious immunosuppressive disease (e.g., human immunodeficiency virus), or has severe autoimmune disease that requires chronic immunosuppressive therapy (e.g., systemic lupus erythematosus, etc.) The patient should also not receive inhibitors of CYP3A (such as Itraconazole, and Erythromycin), or inducers of CYP3A (such as Rifampin) within 90 days following the procedure.
Subject is receiving or is scheduled to receive chronic anticoagulation therapy (e.g., heparin, coumadin)
Use of alternative therapy (e.g. atherectomy, cutting balloon, laser, radiation therapy) as part of the index procedure