DESTINY: Drug Eluting Stents In The Critically Ischemic Lower Leg

Sponsor

Flanders Medical Research Program (Other)

Overall Status

Completed

CT.gov ID

NCT00510393

Collaborator

(none)

140

Enrollment

Locations

Arms

Duration (Months)

Patients Per Site

0.9

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Peripheral Vascular Disease Critical Limb Ischemia	Device: XIENCE V everolimus eluting coronary stent system Device: MULTILINK VISION coronary stent system	Phase 2

Study Design

Study Type:

Interventional

Actual Enrollment :

140 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Participant)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Mar 1, 2008

Actual Primary Completion Date :

Nov 1, 2010

Actual Study Completion Date :

Nov 1, 2010

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 1 drug eluting stent	Device: XIENCE V everolimus eluting coronary stent system
Placebo Comparator: 2 Bare Metal Stent	Device: MULTILINK VISION coronary stent system

Arm

Intervention/Treatment

Experimental: 1

drug eluting stent

Device: XIENCE V everolimus eluting coronary stent system

Placebo Comparator: 2

Bare Metal Stent

Device: MULTILINK VISION coronary stent system

Outcome Measures

Primary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.
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

Contacts and Locations

Locations

	Site	City	Country	Postal Code
1	Imelda Hospital	Bonheiden	Belgium	2820
2	AZ Sint-Blasius	Dendermonde	Belgium	9200
3	Polyclinique Les Fleurs	Ollioules	France	83192
4	Herz-zentrum Bad Krozingen	Bad Krozingen	Germany	79189
5	Herzzentrum	Leipzig	Germany	04289