A Safety and Efficacy Study of the Dynalink®-E Everolimus Eluting Peripheral Stent System - Full Text View

Sponsored by:	Abbott Vascular
Information provided by:	Abbott Vascular
ClinicalTrials.gov Identifier:	NCT00475566

Purpose

The purpose of this first-in-man study is to evaluate the safety and performance of the Dynalink®-E everolimus eluting peripheral stent system for the treatment of patients with atherosclerotic de novo or restenotic native superficial femoral and proximal popliteal lesions.

Condition	Intervention
Atherosclerosis Peripheral Vascular Disease	Device: Dynalink®-E everolimus-eluting peripheral stent Device: Dynalink®-E, everolimus-eluting peripheral stent

MedlinePlus related topics: Peripheral Arterial Disease Vascular Diseases

Drug Information available for: Everolimus

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Historical Control, Single Group Assignment, Safety/Efficacy Study
Official Title:	A Study to Evaluate the Safety and Performance of the Dynalink®-E, Everolimus Eluting Peripheral Stent System for Treating Atherosclerotic de Novo or Restenotic Native Superficial Femoral and Proximal Popliteal Artery Lesions

Further study details as provided by Abbott Vascular:

Primary Outcome Measures:

In-stent binary restenosis (>50% stenosis), as measured by duplex ultrasound [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Angiographic in-stent binary restenosis rate (>50%) [ Time Frame: 12 months ] [ Designated as safety issue: No ]
Angiographic mean in-stent late loss, in-stent mean minimum lumen diameter (MLD), percent diameter stenosis [ Time Frame: 12 months ] [ Designated as safety issue: No ]
Primary, and secondary patency [ Time Frame: 1, 6, 12, 18 months, 2, 3, 4, 5 years ] [ Designated as safety issue: No ]

Enrollment:	104
Study Start Date:	May 2007
Estimated Study Completion Date:	November 2013
Estimated Primary Completion Date:	November 2013 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1 This is a prospective, non-randomized, single-arm, multi-center study. A projected 100 patients will receive the stent(s) in this study at approximately 10-15 European sites. The primary objective is to evaluate the safety and performance of the Dynalink®-E everolimus eluting peripheral stent system for the treatment of patients with atherosclerotic de novo or restenotic native superficial femoral or proximal popliteal lesions.	Device: Dynalink®-E everolimus-eluting peripheral stent Stenting of atherosclerotic de novo or restenotic lesions (> 50% stenosis) in the native superficial femoral or proximal popliteal artery Device: Dynalink®-E, everolimus-eluting peripheral stent Stenting of atherosclerotic de novo or restenotic lesions (> 50% stenosis) in the native superficial femoral or proximal popliteal artery

Arms

Assigned Interventions

1

This is a prospective, non-randomized, single-arm, multi-center study. A projected 100 patients will receive the stent(s) in this study at approximately 10-15 European sites. The primary objective is to evaluate the safety and performance of the Dynalink®-E everolimus eluting peripheral stent system for the treatment of patients with atherosclerotic de novo or restenotic native superficial femoral or proximal popliteal lesions.

Device: Dynalink®-E everolimus-eluting peripheral stent

Stenting of atherosclerotic de novo or restenotic lesions (> 50% stenosis) in the native superficial femoral or proximal popliteal artery

Device: Dynalink®-E, everolimus-eluting peripheral stent

Stenting of atherosclerotic de novo or restenotic lesions (> 50% stenosis) in the native superficial femoral or proximal popliteal artery

Detailed Description:

A prospective, Non-Randomized, Single-arm, Multi-center, Clinical Study to Evaluate the Safety and Performance of the Dynalink®-E, Everolimus Eluting Peripheral Stent System for the Treatment of Atherosclerotic de Novo or Restenotic Native Superficial Femoral and Proximal Popliteal Artery Lesions.

Eligibility

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

Criteria

Inclusion Criteria:

Rutherford Becker Category 2-5
Single de novo or restenotic lesion in the superficial femoral or proximal popliteal artery
Disease segment length 30-170 mm
>50% diameter stenosis or total occlusion
Target reference vessel diameter 4.3-7.3 mm

Exclusion Criteria:

Target lesion previously treated with stent or surgery
Rutherford Becker Category 0, 1, or 6
Immunosuppressive disorder or currently receiving immunosuppressive agents
Serum creatinine >2.5 mg/dl

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00475566

Locations

Austria
Landeskrankenhaus Klagenfurt
Klagenfurt, Austria, 9020
Allgemeines Krankenhaus der Stadt Wien- AKH Wien
Wien, Austria, 1090
Belgium
Sint Blasius Hospital
Dendermonde, Belgium
University Hospital
Gent, Belgium, 9000
ZOL St. Jan
Gent, Belgium, 3600
Germany
The Jewish Hospital Berlin
Berlin, Germany, 13347
Herzzentrum Bad Krozingen
Bad Krozingen, Germany, 79189
Herzzentrum Leipzig
Leipzig, Germany, 04289
University Hospital Tübingen
Tübingen, Germany, 72076
Italy
Casa di Cura di Montevergine
Mercogliano, Italy, 83013

Sponsors and Collaborators

Abbott Vascular

Investigators

Principal Investigator:

Johannes Lammer, M.D.

Allgemeines Krankenhaus der Stadt Wien

More Information

No publications provided

Responsible Party:	Abbott Vascular ( Els Boone )
Study ID Numbers:	06-103
Study First Received:	May 16, 2007
Last Updated:	February 3, 2009
ClinicalTrials.gov Identifier:	NCT00475566 History of Changes
Health Authority:	Belgium: Federal Agency for Medicinal Products and Health Products

Study placed in the following topic categories:

Everolimus
Arterial Occlusive Diseases
Atherosclerosis
Peripheral Vascular Diseases

Immunologic Factors
Vascular Diseases
Arteriosclerosis
Immunosuppressive Agents

Additional relevant MeSH terms:

Everolimus
Arterial Occlusive Diseases
Atherosclerosis
Peripheral Vascular Diseases
Immunologic Factors
Physiological Effects of Drugs

Vascular Diseases
Cardiovascular Diseases
Arteriosclerosis
Immunosuppressive Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 07, 2009