Coronary and Structural Interventions Ulm - Bioresorbable Vascular Scaffold (CSI-Ulm-BVS)

University of Ulm

Status: Completed

Conditions: Ischemic Heart Disease; Coronary Artery Disease; Unstable Angina; Stable Angina; Acute Myocardial Infarction

Treatments: Device: use of bioresorbable vascular scaffolds

Study type: Interventional

Funder types: Other

Identifiers

NCT02162056

CSI-Ulm-BVS 1.0

Details and patient eligibility

About

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

Full description

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

Enrollment: 326 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

• no written informed consent

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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326 participants in 1 patient group

use of bioresorbable vascular scaffolds

Experimental group

Description:

Implantation of bioresorbable vascular scaffold for coronary artery disease.

Treatment:

Device: use of bioresorbable vascular scaffolds