Coronary and Structural Interventions Ulm - Coronary Chronic Total Occlusions (CSI-Ulm-CTO)
April 25, 2020 updated by: Jochen Wohrle, University of Ulm
To evaluate the long-term results after recanalization of coronary chronic total occlusions.
Study Overview
Status
Completed
Intervention / Treatment
Detailed Description
Patients with successful recanalization of coronary chronic total occlusions are followed during a period of 5 years to demonstrate safety and efficacy.
Study Type
Interventional
Enrollment (Actual)
198
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Ulm, Germany, 89081
- University of Ulm
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- coronary artery disease
- chronic total occlusion
Exclusion Criteria:
- no written informed consent
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: stent or scaffold
implantation of stents or scaffolds after recanalization of coronary chronic total occlusions
|
implantation of a CE certified drug-eluting stent, bare-metal stent or scaffold
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Major adverse cardiac events
Time Frame: 1-5 years
|
1-5 years
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
June 1, 2014
Primary Completion (Actual)
December 31, 2018
Study Completion (Actual)
December 31, 2018
Study Registration Dates
First Submitted
June 7, 2014
First Submitted That Met QC Criteria
June 11, 2014
First Posted (Estimate)
June 12, 2014
Study Record Updates
Last Update Posted (Actual)
April 28, 2020
Last Update Submitted That Met QC Criteria
April 25, 2020
Last Verified
April 1, 2020
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CSI Ulm - CTO 1.0
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Undecided
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.