Back to resultsCoronary and Structural Interventions Ulm - Coronary Chronic Total Occlusions (CSI-Ulm-CTO)
Primary Purpose
Coronary Artery Disease, Ischemic Heart Disease, Stable Angina
Status
Completed
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
stent or scaffold
Sponsored by
About this trial
This is an interventional treatment trial for Coronary Artery Disease
Eligibility Criteria
Inclusion Criteria:
- coronary artery disease
- chronic total occlusion
Exclusion Criteria:
- no written informed consent
Sites / Locations
- University of Ulm
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
stent or scaffold
Arm Description
implantation of stents or scaffolds after recanalization of coronary chronic total occlusions
Outcomes
Primary Outcome Measures
Major adverse cardiac events
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02162082
Brief Title
Coronary and Structural Interventions Ulm - Coronary Chronic Total Occlusions
Acronym
CSI-Ulm-CTO
Official Title
Coronary and Structural Interventions Ulm - Coronary Chronic Total Occlusions
Study Type
Interventional
2. Study Status
Record Verification Date
April 2020
Overall Recruitment Status
Completed
Study Start Date
June 2014 (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 long-term results after recanalization of coronary chronic total occlusions.
Detailed Description
Patients with successful recanalization of coronary chronic total occlusions are followed during a period of 5 years to demonstrate safety and efficacy.
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
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
198 (Actual)
8. Arms, Groups, and Interventions
Arm Title
stent or scaffold
Arm Type
Experimental
Arm Description
implantation of stents or scaffolds after recanalization of coronary chronic total occlusions
Intervention Type
Device
Intervention Name(s)
stent or scaffold
Intervention Description
implantation of a CE certified drug-eluting stent, bare-metal stent or scaffold
Primary Outcome Measure Information:
Title
Major adverse cardiac events
Time Frame
1-5 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
coronary artery disease
chronic total occlusion
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
27845998
Citation
Kugler C, Markovic S, Rottbauer W, Wohrle J. Bioresorbable scaffolds compared with everolimus-eluting stents for the treatment of chronic coronary total occlusion: clinical and angiographic results of a matched paired comparison. Coron Artery Dis. 2017 Mar;28(2):120-125. doi: 10.1097/MCA.0000000000000449.
Results Reference
derived
Learn more about this trial
Coronary and Structural Interventions Ulm - Coronary Chronic Total Occlusions
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