Drug Eluting Stents In The Critically Ischemic Lower Leg - Full Text View

Sponsored by:	Flanders Medical Research Program
Information provided by:	Flanders Medical Research Program
ClinicalTrials.gov Identifier:	NCT00510393

Purpose

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	Intervention	Phase
Peripheral Vascular Disease Critical Limb Ischemia	Device: XIENCE V everolimus eluting coronary stent system Device: MULTILINK VISION coronary stent system	Phase II

MedlinePlus related topics: Peripheral Arterial Disease Vascular Diseases

Drug Information available for: Everolimus

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Single Blind (Subject), Placebo Control, Parallel Assignment, Safety/Efficacy Study
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

Further study details as provided by Flanders Medical Research Program:

Primary Outcome Measures:

Angiographic patency, defined as angiographic binary in-stent restenosis rate (>50% stenosis). [ Time Frame: one year ] [ Designated as safety issue: No ]

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. [ Time Frame: procedure ] [ Designated as safety issue: No ]
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. [ Time Frame: one year ] [ Designated as safety issue: No ]
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). [ Time Frame: one year ] [ Designated as safety issue: No ]
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. [ Time Frame: one year ] [ Designated as safety issue: Yes ]
Clinical success defined as an improvement of Rutherford classification of one class or more as compared to the pre-procedure Rutherford classification. [ Time Frame: one year ] [ Designated as safety issue: No ]

Estimated Enrollment:	140
Study Start Date:	March 2008
Estimated Study Completion Date:	March 2010
Estimated Primary Completion Date:	March 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental drug eluting stent	Device: XIENCE V everolimus eluting coronary stent system -
2: Placebo Comparator Bare Metal Stent	Device: MULTILINK VISION coronary stent system -

Detailed Description:

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Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00510393

Contacts

Contact: Koen De Meester

+3252252822

koen.demeester@fmrp.be

Locations

Belgium
AZ Sint-Blasius	Recruiting
Dendermonde, Belgium, 9200
Contact: Marc Bosiers, MD +32 52252822 marc.bosiers@telenet.be
Principal Investigator: Marc Bosiers, MD
Sub-Investigator: Koen Deloose, MD
Imelda Hospital	Recruiting
Bonheiden, Belgium, 2820
Contact: Patrick Peeters, MD +32 15506197 patrick.peeters@imelda.be
Principal Investigator: Patrick Peeters, MD
France
Polyclinique Les Fleurs	Not yet recruiting
Ollioules, France, 83192
Contact: Philippe Commeau, MD p.commeau@wanadoo.fr
Principal Investigator: Philippe Commeau, MD
Germany
Herzzentrum	Not yet recruiting
Leipzig, Germany, 04289
Contact: Dierk Schneinert, MD +49 3418651740 dierk.scheinert@gmx.de
Principal Investigator: Dierk Scheinert, MD
Herz-zentrum Bad Krozingen	Not yet recruiting
Bad Krozingen, Germany, 79189
Contact: Thomas Zeller, MD +49 7633402807 thomas.zeller@herzzentrum.de
Principal Investigator: Thomas Zeller, MD

Sponsors and Collaborators

Flanders Medical Research Program

Investigators

Principal Investigator:	Marc Bosiers, MD	AZ Sint-Blasius, Dendermonde, Belgium
Principal Investigator:	Dierk Scheinert, MD	Herzzentrum, Leipzig, Germany

More Information

Related Info This link exits the ClinicalTrials.gov site

Responsible Party:	Flanders Medical Research Program (FMRP) ( Flanders Medical Research Program (FMRP) )
Study ID Numbers:	FMRP-002
Study First Received:	August 1, 2007
Last Updated:	March 12, 2008
ClinicalTrials.gov Identifier:	NCT00510393
Health Authority:	Belgium: Federal Agency for Medicinal Products and Health Products; Belgium: Institutional Review Board; Germany: Ethics Commission; Germany: Federal Institute for Drugs and Medical Devices; France: Institutional Ethical Committee; France: Direction Générale de la Santé

Keywords provided by Flanders Medical Research Program:

Critical Limb Ischemia
CLI
Drug Eluting Stent

DES
Bare Metal Stent
BMS

Study placed in the following topic categories:

Everolimus
Peripheral Vascular Diseases
Vascular Diseases
Ischemia

Additional relevant MeSH terms:

Pathologic Processes
Cardiovascular Diseases

ClinicalTrials.gov processed this record on January 16, 2009