Drug Eluting Stents In The Critically Ischemic Lower Leg

Critical Limb Ischemia Clinical Trial

— DESTINY  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00510393
• Other study ID #: FMRP-002
• Status: Completed
• Phase: Phase 2
• First received: August 1, 2007
• Last updated: December 1, 2010
• Start date: March 2008
• Est. completion date: November 2010

Study information

• Verified date: December 2010
• Source: Flanders Medical Research Program
• Contact: n/a
• Is FDA regulated: No
• Health authority: Belgium: Federal Agency for Medicinal Products and Health ProductsBelgium: Institutional Review BoardGermany: Ethics CommissionGermany: Federal Institute for Drugs and Medical DevicesFrance: Institutional Ethical CommitteeFrance: Direction Générale de la Santé
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 140
• Est. completion date: November 2010
• Est. primary completion date: November 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Critical Limb Ischemia
• Peripheral Arterial Disease
• Peripheral Vascular Disease
• Peripheral Vascular Diseases
• Vascular Diseases

Intervention

Device:
• XIENCE V everolimus eluting coronary stent system

• MULTILINK VISION coronary stent system

Locations

Country	Name	City	State
Belgium	Imelda Hospital	Bonheiden
Belgium	AZ Sint-Blasius	Dendermonde
France	Polyclinique Les Fleurs	Ollioules
Germany	Herz-zentrum Bad Krozingen	Bad Krozingen
Germany	Herzzentrum	Leipzig

Sponsors (1)

Lead Sponsor	Collaborator
Flanders Medical Research Program

Countries where clinical trial is conducted

Belgium,  France,  Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Angiographic patency, defined as angiographic binary in-stent restenosis rate (>50% stenosis).		one year	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	Yes
Secondary	Clinical success defined as an improvement of Rutherford classification of one class or more as compared to the pre-procedure Rutherford classification.		one year	No

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