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PROGRESS-AMS 1.0 Clinical Long Term Follow-Up

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ClinicalTrials.gov Identifier: NCT01610102
Recruitment Status : Completed
First Posted : June 1, 2012
Last Update Posted : February 5, 2015
Sponsor:
Information provided by (Responsible Party):
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

Condition or disease
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.

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Study Type : Observational
Actual Enrollment : 55 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Clinical Performance and Angiographic Results of Coronary Stenting With Absorbable Metal Stents, Clinical Long Term Follow-Up
Study Start Date : July 2011
Actual Primary Completion Date : June 2012
Actual Study Completion Date : June 2012



Primary Outcome Measures :
  1. Target Lesion Failure (TLF) [ Time Frame: up to 7 years follow-up ]
    Composite of cardiac death, target vessel myocardial infarction, clinically driven target lesion revascularization



Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
63 eligible patints previously enrolled in the PROGRESS AMS-1 study
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01610102


Locations
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Australia, Victoria
Austin & Repatriation Medical Centre
Heidelberg, Victoria, Australia, 3084
Belgium
O.L.V. Ziekenhuis Aalst
Aalst, Belgium, 9300
Germany
Westdeutsches Herzzentrum Essen
Essen, NRW, Germany, 45122
Netherlands
Catharina Zieckenhuis
Eindhoven, Netherlands, 5623
Switzerland
Luzerner Kantonsspital
Luzern, Switzerland
University Hospital Zürich
Zürich, Switzerland
Sponsors and Collaborators
Biotronik AG
Investigators
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Principal Investigator: Raimund Erbel, Prof. Westdeutsches Herzzentrum Essen
Study Director: Esther Gerteis Biotronik AG

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Responsible Party: Biotronik AG
ClinicalTrials.gov Identifier: NCT01610102     History of Changes
Other Study ID Numbers: C1104
First Posted: June 1, 2012    Key Record Dates
Last Update Posted: February 5, 2015
Last Verified: February 2015
Keywords provided by Biotronik AG:
clinical follow-up
up to 7 years
all patients enrolled in the main study