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

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2014 by University of Ulm
Sponsor:
Information provided by (Responsible Party):
Jochen Wohrle, University of Ulm
ClinicalTrials.gov Identifier:
NCT02162082
First received: June 7, 2014
Last updated: July 11, 2014
Last verified: July 2014
  Purpose

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


Condition Intervention Phase
Coronary Artery Disease
Ischemic Heart Disease
Stable Angina
Device: stent or scaffold
Phase 4

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Coronary and Structural Interventions Ulm - Coronary Chronic Total Occlusions

Resource links provided by NLM:


Further study details as provided by University of Ulm:

Primary Outcome Measures:
  • Major adverse cardiac events [ Time Frame: 1-5 years ] [ Designated as safety issue: Yes ]

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • coronary artery disease
  • chronic total occlusion

Exclusion Criteria:

  • no written informed consent
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

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
Study First Received: June 7, 2014
Last Updated: July 11, 2014
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

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

ClinicalTrials.gov processed this record on September 22, 2014