Drug Eluting Stents In The Critically Ischemic Lower Leg

NCT00510393 | Completed Phase 2 DMC

• 1 other identifier: FMRP-002
• Study Type: interventional
• Target: 140
• Locations: 3 countries
• Sites: 5

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

Outcome Measures

Primary Outcomes (1)

• Angiographic patency, defined as angiographic binary in-stent restenosis rate (>50% stenosis).

  one year

Secondary Outcomes (5)

• 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

Study Arms (2)

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

Interventions

XIENCE V everolimus eluting coronary stent system DEVICE

1

MULTILINK VISION coronary stent system DEVICE

2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Flanders Medical Research Program: lead

Study Sites (5)

Imelda Hospital

Bonheiden, 2820, Belgium

Location

AZ Sint-Blasius

Dendermonde, 9200, Belgium

Location

Polyclinique Les Fleurs

Ollioules, 83192, France

Location

Herz-zentrum Bad Krozingen

Bad Krozingen, 79189, Germany

Location

Herzzentrum

Leipzig, 04289, Germany

Location

Related Publications (1)

• 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.

  PMID: 22169682 DERIVED

MeSH Terms

Conditions

Peripheral Vascular Diseases; Chronic Limb-Threatening Ischemia

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases; Peripheral Arterial Disease; Atherosclerosis; Arteriosclerosis; Arterial Occlusive Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Ischemia

Study Officials

• Marc Bosiers, MD

  AZ Sint-Blasius, Dendermonde, Belgium

  PRINCIPAL INVESTIGATOR

• Dierk Scheinert, MD

  Herzzentrum, Leipzig, Germany

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: NETWORK

Study Record Dates

• First Submitted: August 1, 2007
• First Posted: August 2, 2007
• Study Start: March 1, 2008
• Primary Completion: November 1, 2010
• Study Completion: November 1, 2010
• Last Updated: December 2, 2010

Record last verified: 2010-12

Locations

FR (1); DE (2); BE (2)