PROGRESS-AMS 1.0 Clinical Long Term Follow-Up

Long Term Safety of the AMS 1.0 Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01610102
• Other study ID #: C1104
• Status: Completed
• Phase: N/A
• First received: May 30, 2012
• Last updated: February 4, 2015
• Start date: July 2011
• Est. completion date: June 2012

Study information

• Verified date: February 2015
• Source: Biotronik AG
• Contact: n/a
• Is FDA regulated: No
• Health authority: Switzerland: Swissmedic
• Study type: Observational

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 55
• Est. completion date: June 2012
• Est. primary completion date: June 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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

Observational Model: Cohort, Time Perspective: Retrospective

Related Conditions & MeSH terms

• Long Term Safety of the AMS 1.0

Locations

Country	Name	City	State
Australia	Austin & Repatriation Medical Centre	Heidelberg	Victoria
Belgium	O.L.V. Ziekenhuis Aalst	Aalst
Germany	Westdeutsches Herzzentrum Essen	Essen	NRW
Netherlands	Catharina Zieckenhuis	Eindhoven
Switzerland	Luzerner Kantonsspital	Luzern
Switzerland	University Hospital Zürich	Zürich

Sponsors (1)

Lead Sponsor	Collaborator
Biotronik AG

Countries where clinical trial is conducted

Australia,  Belgium,  Germany,  Netherlands,  Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Target Lesion Failure (TLF)	Composite of cardiac death, target vessel myocardial infarction, clinically driven target lesion revascularization	up to 7 years follow-up	Yes