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NCT02162056 Clinical Trial

Coronary and Structural Interventions Ulm - Bioresorbable Vascular Scaffold

Coronary Artery Disease Clinical Trial

— CSI-Ulm-BVS  

Official title:
Coronary and Structural Interventions Ulm - Bioresorbable Vascular Scaffold

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02162056
Other study ID # CSI-Ulm-BVS 1.0
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date November 2013
Est. completion date December 31, 2018

Study information
Verified date April 2020
Source University of Ulm
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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

Description:

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

Recruitment information / eligibility
Status Completed
Enrollment 326
Est. completion date December 31, 2018
Est. primary completion date December 31, 2018
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria:

- coronary artery disease

- implantation of at least one bioresorbable vascular scaffold

Exclusion Criteria:

- no written informed consent

Study Design

Related Conditions & MeSH terms

Intervention

Device:
• use of bioresorbable vascular scaffolds
Implantation of bioresorbable vascular scaffolds for coronary artery disease.

Locations
Country Name City State
Germany University of Ulm Ulm

Sponsors (1)
Lead Sponsor Collaborator
University of Ulm

Country where clinical trial is conducted

Germany, 

References & Publications (1)

Reichart C, Wöhrle J, Markovic S, Rottbauer W, Seeger J. Clinical results of bioresorbable drug-eluting scaffolds in short and long coronary artery lesions using the PSP technique. BMC Cardiovasc Disord. 2019 Jan 18;19(1):22. doi: 10.1186/s12872-018-0994- — View Citation

Outcome
Type Measure Description Time frame Safety issue
Primary Major Adverse Cardiac Events 10 years
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