Coronary and Structural Interventions Ulm - Bioresorbable Vascular Scaffold
CSI-Ulm-BVS
1 other identifier
interventional
326
1 country
1
Brief Summary
To evaluate the safety, performance and efficacy of the bioresorbable vascular scaffold (BVS) system in patients with coronary artery disease
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable coronary-artery-disease
Started Nov 2013
Longer than P75 for not_applicable coronary-artery-disease
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2013
CompletedFirst Submitted
Initial submission to the registry
June 7, 2014
CompletedFirst Posted
Study publicly available on registry
June 12, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2018
CompletedApril 28, 2020
April 1, 2020
5.2 years
June 7, 2014
April 25, 2020
Conditions
Outcome Measures
Primary Outcomes (1)
Major Adverse Cardiac Events
10 years
Study Arms (1)
use of bioresorbable vascular scaffolds
EXPERIMENTALImplantation of bioresorbable vascular scaffold for coronary artery disease.
Interventions
Implantation of bioresorbable vascular scaffolds for coronary artery disease.
Eligibility Criteria
You may qualify if:
- coronary artery disease
- implantation of at least one bioresorbable vascular scaffold
You may not qualify if:
- no written informed consent
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of Ulm
Ulm, 89081, Germany
Related Publications (3)
Reichart C, Wohrle 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-y.
PMID: 30658574RESULTMarkovic S, Kugler C, Rottbauer W, Wohrle J. Long-term clinical results of bioresorbable absorb scaffolds using the PSP-technique in patients with and without diabetes. J Interv Cardiol. 2017 Aug;30(4):325-330. doi: 10.1111/joic.12392. Epub 2017 Jun 1.
PMID: 28568564DERIVEDMarkovic S, Dragomir S, Walcher D, Bernhardt P, Imhof A, Rottbauer W, Wohrle J. Clinical results of single and multiple bioresorbable drug-eluting scaffolds for treatment of de-novo coronary artery disease. Coron Artery Dis. 2016 Nov;27(7):561-5. doi: 10.1097/MCA.0000000000000392.
PMID: 27244371DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jochen Wöhrle, MD
University of Ulm, Ulm, Germany
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Prof. Dr. Jochen Wöhrle
Study Record Dates
First Submitted
June 7, 2014
First Posted
June 12, 2014
Study Start
November 1, 2013
Primary Completion
December 31, 2018
Study Completion
December 31, 2018
Last Updated
April 28, 2020
Record last verified: 2020-04