PROGRESS-AMS 1.0 Clinical Long Term Follow-Up

Clinical Performance and Angiographic Results of Coronary Stenting With Absorbable Metal Stents, Clinical Long Term Follow-Up

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

Study Overview

• Status: Completed
• Conditions: 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 Type: Observational
• Enrollment (Actual): 55

Contacts and Locations

Study Locations

• Australia
  • Victoria
    • Heidelberg, Victoria, Australia, 3084
      • Austin & Repatriation Medical Centre
• Belgium
  • Aalst, Belgium, 9300
    • O.L.V. Ziekenhuis Aalst
• Germany
  • NRW
    • Essen, NRW, Germany, 45122
      • Westdeutsches Herzzentrum Essen
• Netherlands
  • Eindhoven, Netherlands, 5623
    • Catharina Zieckenhuis
• Switzerland
  • Luzern, Switzerland
    • Luzerner Kantonsspital
  • Zürich, Switzerland
    • University Hospital Zurich

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

63 eligible patints previously enrolled in the PROGRESS AMS-1 study

Description

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 Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Biotronik AG
• Investigators: Study Director: Esther Gerteis, Biotronik AG; Principal Investigator: Raimund Erbel, Prof., Westdeutsches Herzzentrum Essen

Study record dates

Study Major Dates

• Study Start: July 1, 2011
• Primary Completion (Actual): June 1, 2012
• Study Completion (Actual): June 1, 2012

Study Registration Dates

• First Submitted: May 30, 2012
• First Submitted That Met QC Criteria: May 31, 2012
• First Posted (Estimate): June 1, 2012

Study Record Updates

• Last Update Posted (Estimate): February 5, 2015
• Last Update Submitted That Met QC Criteria: February 4, 2015
• Last Verified: February 1, 2015

More Information

Terms related to this study

• Keywords: clinical follow-up; up to 7 years; all patients enrolled in the main study
• Other Study ID Numbers: C1104