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

Flanders Medical Research Program5 sites in 3 countries140 target enrollmentMarch 2008

ConditionsPeripheral Vascular Disease Critical Limb Ischemia

Overview

Phase: Phase 2
Intervention: Not specified
Conditions: Peripheral Vascular Disease
Sponsor: Flanders Medical Research Program
Enrollment: 140
Locations: 5
Primary Endpoint: Angiographic patency, defined as angiographic binary in-stent restenosis rate (>50% stenosis).
Status: Completed
Last Updated: 15 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

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.

Registry

clinicaltrials.gov

Start Date

March 2008

End Date

November 2010

Last Updated

15 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Flanders Medical Research Program

Eligibility Criteria

Inclusion Criteria

•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
•Reference vessel diameter should be 2-3.5 mm
•Symptomatic critical limb ischemia (Rutherford 4, 5)
•The patient must be \> 18 years of age
•Life-expectancy of more than 12 months
•The patient has no child bearing potential or negative serum pregnancy test within 7 days of the index procedure
•The patient must be willing and able to return to the appropriate follow-up times for the duration of the study
•The patient must provide written patient informed consent that is approved by the ethics committee

Exclusion Criteria

•Patient refusing treatment
•The reference segment diameter is not suitable for available stent design.
•Unsuccessfully treated (\>30% residual stenosis) proximal inflow limiting arterial stenosis
•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.

Outcomes

Primary Outcomes

Angiographic patency, defined as angiographic binary in-stent restenosis rate (>50% stenosis).

Time Frame: one year

Secondary Outcomes

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.(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.(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).(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.(one year)
Clinical success defined as an improvement of Rutherford classification of one class or more as compared to the pre-procedure Rutherford classification.(one year)