Drug Eluting Stents In The Critically Ischemic Lower Leg

Phase 2

Completed

• Conditions: Peripheral Vascular Disease; Critical Limb Ischemia
• Interventions: Device: XIENCE V everolimus eluting coronary stent system; Device: MULTILINK VISION coronary stent system

• Registration Number: NCT00510393
• Lead Sponsor: Flanders Medical Research Program

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2007-08-01
• Study First Submitted QC: 2007-08-01
• Study First Posted: 2007-08-02
• Study Start: 2008-03
• Primary Completion: 2010-11
• Study Completion: 2010-11
• Status Verified: 2010-12
• Last Update Submitted: 2010-12-01
• Last Update Posted: 2010-12-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 140

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	XIENCE V everolimus eluting coronary stent system	drug eluting stent
2	MULTILINK VISION coronary stent system	Bare Metal Stent

Primary Outcome Measures

Name	Time	Method
Angiographic patency, defined as angiographic binary in-stent restenosis rate (>50% stenosis).	one year

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (5)

Imelda Hospital; 🇧🇪 Bonheiden, Belgium

Polyclinique Les Fleurs; 🇫🇷 Ollioules, France

Herz-zentrum Bad Krozingen; 🇩🇪 Bad Krozingen, Germany

AZ Sint-Blasius; 🇧🇪 Dendermonde, Belgium

Herzzentrum; 🇩🇪 Leipzig, Germany