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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02162056
Recruitment Status : Completed
First Posted : June 12, 2014
Last Update Posted : April 28, 2020
Sponsor:
Information provided by (Responsible Party):
Jochen Wohrle, 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

Condition or disease Intervention/treatment Phase
Coronary Artery Disease Ischemic Heart Disease Stable Angina Unstable Angina Acute Myocardial Infarction Device: use of bioresorbable vascular scaffolds Not Applicable

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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 326 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Coronary and Structural Interventions Ulm - Bioresorbable Vascular Scaffold
Study Start Date : November 2013
Actual Primary Completion Date : December 31, 2018
Actual Study Completion Date : December 31, 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: use of bioresorbable vascular scaffolds
Implantation of bioresorbable vascular scaffold for coronary artery disease.
Device: use of bioresorbable vascular scaffolds
Implantation of bioresorbable vascular scaffolds for coronary artery disease.




Primary Outcome Measures :
  1. Major Adverse Cardiac Events [ Time Frame: 10 years ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • no written informed consent

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02162056


Locations
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Germany
University of Ulm
Ulm, Germany, 89081
Sponsors and Collaborators
University of Ulm
Investigators
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Principal Investigator: Jochen Wöhrle, MD University of Ulm, Ulm, Germany
Publications of Results:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Jochen Wohrle, Prof. Dr. Jochen Wöhrle, University of Ulm
ClinicalTrials.gov Identifier: NCT02162056    
Other Study ID Numbers: CSI-Ulm-BVS 1.0
First Posted: June 12, 2014    Key Record Dates
Last Update Posted: April 28, 2020
Last Verified: April 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Additional relevant MeSH terms:
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Coronary Artery Disease
Myocardial Ischemia
Heart Diseases
Myocardial Infarction
Angina Pectoris
Angina, Stable
Angina, Unstable
Infarction
Ischemia
Pathologic Processes
Necrosis
Coronary Disease
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Chest Pain
Pain
Neurologic Manifestations