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Coronary and Structural Interventions Ulm - Coronary Chronic Total Occlusions (CSI-Ulm-CTO)

This study is currently recruiting participants.
Verified April 2017 by Jochen Wohrle, University of Ulm
Sponsor:
ClinicalTrials.gov Identifier:
NCT02162082
First Posted: June 12, 2014
Last Update Posted: April 5, 2017
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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
Jochen Wohrle, University of Ulm
  Purpose
To evaluate the long-term results after recanalization of coronary chronic total occlusions.

Condition Intervention
Coronary Artery Disease Ischemic Heart Disease Stable Angina Device: stent or scaffold

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Coronary and Structural Interventions Ulm - Coronary Chronic Total Occlusions

Further study details as provided by Jochen Wohrle, University of Ulm:

Primary Outcome Measures:
  • Major adverse cardiac events [ Time Frame: 1-5 years ]

Estimated Enrollment: 500
Study Start Date: June 2014
Estimated Study Completion Date: December 2026
Estimated Primary Completion Date: December 2019 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: stent or scaffold
implantation of stents or scaffolds after recanalization of coronary chronic total occlusions
Device: stent or scaffold
implantation of a CE certified drug-eluting stent, bare-metal stent or scaffold

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

Information from the National Library of Medicine

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

Inclusion Criteria:

  • coronary artery disease
  • chronic total occlusion

Exclusion Criteria:

  • no written informed consent
  Contacts and Locations
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): NCT02162082


Contacts
Contact: Jochen Wöhrle, MD +49 731 500 ext 45047 jochen.woehrle@uniklinik-ulm.de

Locations
Germany
University of Ulm Recruiting
Ulm, Germany, 89081
Contact: Jochen Wöhrle, MD    ++49 731 500 ext 45047    jochen.woehrle@uniklinik-ulm.de   
Principal Investigator: Jochen Wöhrle, MD         
Sponsors and Collaborators
University of Ulm
Investigators
Principal Investigator: Jochen Wöhrle, MD University of Ulm, Ulm, Germany
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Jochen Wohrle, Prof. Dr. Jochen Wöhrle, University of Ulm
ClinicalTrials.gov Identifier: NCT02162082     History of Changes
Other Study ID Numbers: CSI Ulm - CTO 1.0
First Submitted: June 7, 2014
First Posted: June 12, 2014
Last Update Posted: April 5, 2017
Last Verified: April 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Additional relevant MeSH terms:
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Heart Diseases
Angina, Stable
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Angina Pectoris
Chest Pain
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms