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

Atherosclerosis Clinical Trial

— STRIDES  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00475566
• Other study ID #: 06-103
• Status: Completed
• Phase: N/A
• First received: May 16, 2007
• Last updated: March 9, 2011
• Start date: May 2007
• Est. completion date: February 2010

Study information

• Verified date: March 2011
• Source: Abbott Vascular
• Contact: n/a
• Is FDA regulated: No
• Health authority: Belgium: Federal Agency for Medicinal Products and Health Products
• Study type: Interventional

Clinical Trial Summary

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.

Abbott Vascular is ceasing data analysis of the STRIDES Clinical Trial after 2 years. The decision to discontinue the study is not related to any safety concern. The rationale for this proposal is based on the following considerations:

The performance of DYNALINK-E from STRIDES shows no device- or procedure-related deaths and no stent fractures, and the rate of additional revascularizations has been stable since approximately 14 months after the procedure.

Evaluations of the bare metal nitinol DYNALINK and ABSOLUTE stents in the clinical literature show low rates of death, reintervention and stent fracture, which are consistent with STRIDES and demonstrate the safety of the nitinol stent platform of the DYNALINK-E.

Long-term animal studies show no concerns with the drug or polymer coating of DYNALINK-E - everolimus tissue concentration drops below the quantifiable limit by approximately 17 months after implant, and vascular response to the coating is normal with widely patent lumens and struts incorporated into vessel tissue.

The safety and performance of the DYNALINK-E has been substantiated by its clinical and pre-clinical data, and by the clinical data of similar products. Given the demonstrated mechanical integrity of the stent along with the evidence of a healthy long-term vascular response, there is a reasonable expectation of continued low event rates.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 104
• Est. completion date: February 2010
• Est. primary completion date: July 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Atherosclerosis
• Peripheral Arterial Disease
• Peripheral Vascular Disease
• Peripheral Vascular Diseases
• Vascular Diseases

Intervention

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
• 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

Locations

Country	Name	City	State
Austria	Landeskrankenhaus Klagenfurt	Klagenfurt
Austria	Allgemeines Krankenhaus der Stadt Wien- AKH Wien	Wien
Belgium	Sint Blasius Hospital	Dendermonde
Belgium	University Hospital	Gent
Belgium	ZOL St. Jan	Gent
Germany	Herzzentrum Bad Krozingen	Bad Krozingen
Germany	The Jewish Hospital Berlin	Berlin
Germany	Herzzentrum Leipzig	Leipzig
Germany	University Hospital Tübingen	Tübingen
Italy	Casa di Cura di Montevergine	Mercogliano

Sponsors (1)

Lead Sponsor	Collaborator
Abbott Vascular

Countries where clinical trial is conducted

Austria,  Belgium,  Germany,  Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	In-stent binary restenosis (>50% stenosis), as measured by duplex ultrasound		6 months	No
Secondary	Angiographic in-stent binary restenosis rate (>50%)		12 months	No
Secondary	Angiographic mean in-stent late loss, in-stent mean minimum lumen diameter (MLD), percent diameter stenosis		12 months	No
Secondary	Primary, and secondary patency		1, 6, 12, 18 months, 2, 3, 4, 5 years	No