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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00510393
Other study ID # FMRP-002
Secondary ID
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


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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