Back to resultsCoronary and Structural Interventions Ulm - Bioresorbable Vascular Scaffold (CSI-Ulm-BVS)
Primary Purpose
Coronary Artery Disease, Ischemic Heart Disease, Stable Angina
Status
Completed
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
use of bioresorbable vascular scaffolds
Sponsored by
About this trial
This is an interventional treatment trial for Coronary Artery Disease
Eligibility Criteria
Inclusion Criteria:
- coronary artery disease
- implantation of at least one bioresorbable vascular scaffold
Exclusion Criteria:
- no written informed consent
Sites / Locations
- University of Ulm
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
use of bioresorbable vascular scaffolds
Arm Description
Implantation of bioresorbable vascular scaffold for coronary artery disease.
Outcomes
Primary Outcome Measures
Major Adverse Cardiac Events
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02162056
Brief Title
Coronary and Structural Interventions Ulm - Bioresorbable Vascular Scaffold
Acronym
CSI-Ulm-BVS
Official Title
Coronary and Structural Interventions Ulm - Bioresorbable Vascular Scaffold
Study Type
Interventional
2. Study Status
Record Verification Date
April 2020
Overall Recruitment Status
Completed
Study Start Date
November 2013 (undefined)
Primary Completion Date
December 31, 2018 (Actual)
Study Completion Date
December 31, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Ulm
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary Artery Disease, Ischemic Heart Disease, Stable Angina, Unstable Angina, Acute Myocardial Infarction
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
326 (Actual)
8. Arms, Groups, and Interventions
Arm Title
use of bioresorbable vascular scaffolds
Arm Type
Experimental
Arm Description
Implantation of bioresorbable vascular scaffold for coronary artery disease.
Intervention Type
Device
Intervention Name(s)
use of bioresorbable vascular scaffolds
Intervention Description
Implantation of bioresorbable vascular scaffolds for coronary artery disease.
Primary Outcome Measure Information:
Title
Major Adverse Cardiac Events
Time Frame
10 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
coronary artery disease
implantation of at least one bioresorbable vascular scaffold
Exclusion Criteria:
no written informed consent
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jochen Wöhrle, MD
Organizational Affiliation
University of Ulm, Ulm, Germany
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Ulm
City
Ulm
ZIP/Postal Code
89081
Country
Germany
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Citations:
PubMed Identifier
30658574
Citation
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.
Results Reference
result
PubMed Identifier
28568564
Citation
Markovic 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.
Results Reference
derived
PubMed Identifier
27244371
Citation
Markovic 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.
Results Reference
derived
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Coronary and Structural Interventions Ulm - Bioresorbable Vascular Scaffold
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