Coronary and Structural Interventions Ulm - Bioresorbable Vascular Scaffold

Not Applicable

Completed

• Conditions: Coronary Artery Disease; Ischemic Heart Disease; Stable Angina; Acute Myocardial Infarction; Unstable Angina
• Interventions: Device: use of bioresorbable vascular scaffolds

• Registration Number: NCT02162056
• Lead Sponsor: University of Ulm

Brief Summary

To evaluate the safety, performance and efficacy of the bioresorbable vascular scaffold (BVS) system in patients with coronary artery disease

Detailed Description

Patients with coronary artery disease receive bioabsorbable vascular scaffolds. Patients are clinically followed during a period of 10 years.

Study Timeline

• Study Start: 2013-11
• Study First Submitted: 2014-06-07
• Study First Submitted QC: 2014-06-11
• Study First Posted: 2014-06-12
• Primary Completion: 2018-12-31
• Study Completion: 2018-12-31
• Status Verified: 2020-04
• Last Update Submitted: 2020-04-25
• Last Update Posted: 2020-04-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 326

Inclusion Criteria

• coronary artery disease
• implantation of at least one bioresorbable vascular scaffold

Exclusion Criteria

• no written informed consent

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
use of bioresorbable vascular scaffolds	use of bioresorbable vascular scaffolds	Implantation of bioresorbable vascular scaffold for coronary artery disease.

Primary Outcome Measures

Name	Time	Method
Major Adverse Cardiac Events	10 years

Trial Locations

Locations (1)

University of Ulm; 🇩🇪 Ulm, Germany