Drug Eluting Stents In The Critically Ischemic Lower Leg

NCT ID: NCT00510393

Last Updated: 2010-12-02

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 140 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-03-31
• Study Completion Date: 2010-11-30

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.

Conditions

Peripheral Vascular Disease; Critical Limb Ischemia

Keywords

Critical Limb Ischemia; CLI; Drug Eluting Stent; DES; Bare Metal Stent; BMS

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

1

drug eluting stent

Group Type: EXPERIMENTAL

XIENCE V everolimus eluting coronary stent system

Intervention Type: DEVICE

2

Bare Metal Stent

Group Type: PLACEBO_COMPARATOR

MULTILINK VISION coronary stent system

Intervention Type: DEVICE

Interventions

XIENCE V everolimus eluting coronary stent system

Intervention Type: DEVICE

MULTILINK VISION coronary stent system

Intervention Type: DEVICE

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.
• 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Flanders Medical Research Program

NETWORK

Sponsor Role: lead

Responsible Party

Flanders Medical Research Program (FMRP)

Principal Investigators

Marc Bosiers, MD

Role: PRINCIPAL_INVESTIGATOR

AZ Sint-Blasius, Dendermonde, Belgium

Dierk Scheinert, MD

Role: PRINCIPAL_INVESTIGATOR

Herzzentrum, Leipzig, Germany

Locations

Imelda Hospital

Bonheiden, , Belgium

AZ Sint-Blasius

Dendermonde, , Belgium

Polyclinique Les Fleurs

Ollioules, , France

Herz-zentrum Bad Krozingen

Bad Krozingen, , Germany

Herzzentrum

Leipzig, , Germany

Countries

Belgium; France; Germany

References

Bosiers M, Scheinert D, Peeters P, Torsello G, Zeller T, Deloose K, Schmidt A, Tessarek J, Vinck E, Schwartz LB. Randomized comparison of everolimus-eluting versus bare-metal stents in patients with critical limb ischemia and infrapopliteal arterial occlusive disease. J Vasc Surg. 2012 Feb;55(2):390-8. doi: 10.1016/j.jvs.2011.07.099. Epub 2011 Dec 14.

Reference Type: DERIVED

PMID: 22169682 (View on PubMed)

Other Identifiers

FMRP-002

Identifier Type: -

Identifier Source: org_study_id