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NCT04650139 Clinical Trial

Coronary Interventions Ulm - Coronary Chronic Total Occlusions

Chronic Total Occlusion of Coronary Artery Clinical Trial

— CSI  

Official title:
Coronary Interventions Ulm - Coronary Chronic Total Occlusions

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT04650139
Other study ID # 0925-0586
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date January 1, 2014
Est. completion date January 1, 2025

Study information
Verified date November 2020
Source University Hospital Ulm
Contact n/a
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial Summary

The aim of the proposed project is to provide the long-term results after a recanalization attempt of chronically occluded coronary arteries. To investigate recanalization attempt of chronically occluded coronary arteries at the Ulm University Hospital. As shown, it is known that successful recanalization of a chronic occlusion is associated with a lower event rate (reduced mortality and the need for operative myocardial revascularization) compared to unsuccessful recanalization (drug therapy). The standard in the therapy of successfully recanalized chronic occlusions is the use of drug-releasing vascular supports.

Recruitment information / eligibility
Status Recruiting
Enrollment 500
Est. completion date January 1, 2025
Est. primary completion date January 1, 2024
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Patients over 18 years Coronary intervention in chronic coronary artery occlusion Occlusion > 3 months Indication for PTCA or recanalization according to guidlines such as: Symptoms of the patient Evidence of myocardial ischemia (stress ECG, scintigraphic Methods, magnetic resonance imaging, stress echocardiography) pathological intracoronary flow reserve, prognostic Exclusion Criteria: - No chronic occlusion, - Contraindication to anti-platelet therapy Acetylsalicylic acid plus clopidogrel for at least 3 months such as e.g. with florid gastrointestinal ulcer disease, History of hemorrhagic stroke or urgent non-postponable surgical intervention. Basic disease with a life expectancy of less than 12 months (here as a rule no indication for PTCA or reopening available)

Study Design

Related Conditions & MeSH terms

Intervention

Procedure:
• PCI - percutaneous coronary intervention
percutaneous coronary intervention

Locations
Country Name City State
Germany University Ulm Ulm

Sponsors (1)
Lead Sponsor Collaborator
University Hospital Ulm

Country where clinical trial is conducted

Germany, 

Outcome
Type Measure Description Time frame Safety issue
Primary MACE major adverse cardiac event 1 year
Secondary TLR target lesion revascularization 1 year
See also
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Recruiting NCT05142215 - A Placebo-controlled Trial of Chronic Total Occlusion Percutaneous Coronary Intervention for the Relief of Stable Angina N/A
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Recruiting NCT04145167 - Observational Registry on Clinical Outcome After Diagnosis of Chronic Total Occlusions
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Completed NCT05377866 - Holo CTO Proctoring Study
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Withdrawn NCT02784418 - The SHINE-CTO Trial N/A
Completed NCT03988166 - Chronic Total Occlusion Percutaneous Coronary Intervention Study N/A
Completed NCT02477579 - A Prospective, Multi-Center, Pivotal Study to Evaluate the Safety and Effectiveness of the NovaCross™ Micro-catheter in Facilitating Crossing Chronic Total Occlusion (CTO) Coronary Lesions N/A
Not yet recruiting NCT06193954 - VasoStar Vibrational Guidewire System to Facilitate Crossing Coronary Artery Chronic Total Occlusions N/A
Completed NCT03209843 - Post-stenting Assessment of Reendothelialization With OFDI After CTO Procedure (PERFECTO) N/A
Completed NCT03947398 - The BLIMP Balloon in Coronary Interventions N/A