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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01610102

Enrollment

Registered

2012-06-01

Start date

2011-07-31

Completion date

2012-06-30

Last updated

2015-02-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Long Term Safety of the AMS 1.0

Keywords

clinical follow-up, up to 7 years, all patients enrolled in the main study

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

RETROSPECTIVE

Eligibility

Sex/Gender

ALL

Healthy volunteers

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

Design outcomes

Primary

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

Countries

Australia, Belgium, Germany, Netherlands, Switzerland

Outcome results