Drug Eluting Stents In The Critically Ischemic Lower Leg (DESTINY)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00510393
Recruitment Status : Completed
First Posted : August 2, 2007
Last Update Posted : December 2, 2010
Information provided by:
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.

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 Type : Interventional  (Clinical Trial)
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 : March 2008
Primary Completion Date : November 2010
Study Completion Date : November 2010

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

Primary Outcome Measures :
  1. Angiographic patency, defined as angiographic binary in-stent restenosis rate (>50% stenosis). [ Time Frame: one year ]

Secondary Outcome Measures :
  1. 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 ]
  2. 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 ]
  3. 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 ]
  4. 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 ]
  5. 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 ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00510393

Imelda Hospital
Bonheiden, Belgium, 2820
AZ Sint-Blasius
Dendermonde, Belgium, 9200
Polyclinique Les Fleurs
Ollioules, France, 83192
Herz-zentrum Bad Krozingen
Bad Krozingen, Germany, 79189
Leipzig, Germany, 04289
Sponsors and Collaborators
Flanders Medical Research Program
Principal Investigator: Marc Bosiers, MD AZ Sint-Blasius, Dendermonde, Belgium
Principal Investigator: Dierk Scheinert, MD Herzzentrum, Leipzig, Germany

Additional Information:
Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Flanders Medical Research Program (FMRP) Identifier: NCT00510393     History of Changes
Other Study ID Numbers: FMRP-002
First Posted: August 2, 2007    Key Record Dates
Last Update Posted: December 2, 2010
Last Verified: December 2010

Keywords provided by Flanders Medical Research Program:
Critical Limb Ischemia
Drug Eluting Stent
Bare Metal Stent

Additional relevant MeSH terms:
Vascular Diseases
Peripheral Vascular Diseases
Peripheral Arterial Disease
Pathologic Processes
Cardiovascular Diseases
Arterial Occlusive Diseases
Antineoplastic Agents
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs