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

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: NCT02162082
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 long-term results after recanalization of coronary chronic total occlusions.

Condition or disease Intervention/treatment Phase
Coronary Artery Disease Ischemic Heart Disease Stable Angina Device: stent or scaffold Not Applicable

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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 198 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Coronary and Structural Interventions Ulm - Coronary Chronic Total Occlusions
Study Start Date : June 2014
Actual Primary Completion Date : December 31, 2018
Actual Study Completion Date : December 31, 2018

Arm Intervention/treatment
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




Primary Outcome Measures :
  1. Major adverse cardiac events [ Time Frame: 1-5 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
  • chronic total occlusion

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): NCT02162082


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 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: NCT02162082    
Other Study ID Numbers: CSI Ulm - CTO 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
Angina, Stable
Coronary Disease
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Angina Pectoris
Chest Pain
Pain
Neurologic Manifestations