CSI-Ulm-CTO: Coronary and Structural Interventions Ulm - Coronary Chronic Total Occlusions

• Sponsor: University of Ulm (Other)
• Overall Status: Completed
• CT.gov ID: NCT02162082
• Collaborator: (none)
• Enrollment: 198
• Location: 1
• Arm: 1
• Duration (Months): 55
• Patients Per Site Per Month: 3.6

Study Details

Study Description

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	N/A

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 Design

• Study Type: Interventional
• 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: Jun 1, 2014
• Actual Primary Completion Date: Dec 31, 2018
• Actual Study Completion Date: Dec 31, 2018

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Major adverse cardiac events [1-5 years]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• coronary artery disease

• chronic total occlusion

Exclusion Criteria:

• no written informed consent

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Ulm	Ulm		Germany	89081

Sponsors and Collaborators

• University of Ulm

Investigators

• Principal Investigator: Jochen Wöhrle, MD, University of Ulm, Ulm, Germany

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• 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: Jun 12, 2014
• Last Update Posted: Apr 28, 2020
• Last Verified: Apr 1, 2020

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Additional relevant MeSH terms: Coronary Artery Disease; Myocardial Ischemia; Heart Diseases; Angina, Stable

Study Results

No Results Posted as of Apr 28, 2020