PROGRESS-AMS 1.0 Clinical Long Term Follow-Up

Completed

• Conditions: Long Term Safety of the AMS 1.0

• Registration Number: NCT01610102
• Lead Sponsor: Biotronik AG

Brief Summary

The primary objective of this study is to collect long term clinical follow-up data on all patients enrolled in the PROGRESS AMS-1.0 study to assess long term safety of the AMS-1.0

Detailed Description

The first clinical experience with AMS was in infrapopliteal arteries and demonstrated safety and acceptable patency rates up to 12 months post implantation. These encouraging results led to the initiation of the first trial to treat human coronary lesions with AMS named Clinical Performance and angiographic Results of Coronary Stenting with Absorbable Metal Stents (PROGRESS AMS-1). Although an ischemic driven target lesion revascularization rate of 26.7% (16/60) was observed during the PROGRESS AMS-1 study, it demonstrated that biodegradable magnesium stents can be implanted safely in coronary arteries, and the stents degraded as intended without causing stent thrombosis, myocardial infarction or death at one year. No adverse device effects from the absorbable nature of the stents or its constituents were detected. The continued clinical follow-up and retrospective evaluation of all angiographies and IVUS films on all eligible patients enrolled in the PROGRESS-AMS 1.0 will give important information on the long term safety of absorbable metal scaffolds and thus can support improvement of the device.

Study Timeline

• Study Start: 2011-07
• Study First Submitted: 2012-05-30
• Study First Submitted QC: 2012-05-31
• Primary Completion: 2012-06
• Study Completion: 2012-06
• Study First Posted: 2012-06-01
• Status Verified: 2015-02
• Last Update Submitted: 2015-02-04
• Last Update Posted: 2015-02-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 55

Inclusion Criteria

• Signed informed consent form available prior to clinical long term follow-up

Exclusion Criteria

• Patent did not sign the informed consent form prior to clinical long term follow-up

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Target Lesion Failure (TLF)	up to 7 years follow-up	Composite of cardiac death, target vessel myocardial infarction, clinically driven target lesion revascularization

Trial Locations

Locations (6)

Luzerner Kantonsspital; 🇨🇭 Luzern, Switzerland

Catharina Zieckenhuis; 🇳🇱 Eindhoven, Netherlands

University Hospital Zürich; 🇨🇭 Zürich, Switzerland

O.L.V. Ziekenhuis Aalst; 🇧🇪 Aalst, Belgium

Austin & Repatriation Medical Centre; 🇦🇺 Heidelberg, Victoria, Australia

Westdeutsches Herzzentrum Essen; 🇩🇪 Essen, NRW, Germany