PROGRESS-AMS 1.0 Clinical Long Term Follow-Up

NCT ID: NCT01610102

Last Updated: 2015-02-05

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 55 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2011-07-31
• Study Completion Date: 2012-06-30

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.

Conditions

Long Term Safety of the AMS 1.0

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: RETROSPECTIVE

Eligibility Criteria

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

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Biotronik AG

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Raimund Erbel, Prof.

Role: PRINCIPAL_INVESTIGATOR

Westdeutsches Herzzentrum Essen

Esther Gerteis

Role: STUDY_DIRECTOR

Biotronik AG

Locations

Austin & Repatriation Medical Centre

Heidelberg, Victoria, Australia

O.L.V. Ziekenhuis Aalst

Aalst, , Belgium

Westdeutsches Herzzentrum Essen

Essen, North Rhine-Westphalia, Germany

Catharina Zieckenhuis

Eindhoven, , Netherlands

Luzerner Kantonsspital

Lucerne, , Switzerland

University Hospital Zürich

Zurich, , Switzerland

Countries

Australia; Belgium; Germany; Netherlands; Switzerland

Other Identifiers

C1104

Identifier Type: -

Identifier Source: org_study_id