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NCT02162082 Clinical Trial

Coronary and Structural Interventions Ulm - Coronary Chronic Total Occlusions

Coronary Artery Disease Clinical Trial

— CSI-Ulm-CTO  

Official title:
Coronary and Structural Interventions Ulm - Coronary Chronic Total Occlusions

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02162082
Other study ID # CSI Ulm - CTO 1.0
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date June 2014
Est. completion date December 31, 2018

Study information
Verified date April 2020
Source University of Ulm
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

To evaluate the long-term results after recanalization of coronary chronic total occlusions.

Description:

Patients with successful recanalization of coronary chronic total occlusions are followed during a period of 5 years to demonstrate safety and efficacy.

Recruitment information / eligibility
Status Completed
Enrollment 198
Est. completion date December 31, 2018
Est. primary completion date December 31, 2018
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria:

- coronary artery disease

- chronic total occlusion

Exclusion Criteria:

- no written informed consent

Study Design

Related Conditions & MeSH terms

Intervention

Device:
• stent or scaffold
implantation of a CE certified drug-eluting stent, bare-metal stent or scaffold

Locations
Country Name City State
Germany University of Ulm Ulm

Sponsors (1)
Lead Sponsor Collaborator
University of Ulm

Country where clinical trial is conducted

Germany, 

Outcome
Type Measure Description Time frame Safety issue
Primary Major adverse cardiac events 1-5 years
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