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NCT04533633 Clinical Trial

German Epicardial Collateral CTO Registry

Coronary Artery Disease Clinical Trial

— EPIC  

Official title:
German Multicentre Registry to Evaluate the Technical Feasibilty of Epicardial Collateral Connections in CTO PCI

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT04533633
Other study ID # 2017-838R-MA
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date January 1, 2018
Est. completion date December 31, 2022

Study information
Verified date August 2020
Source Universitätsmedizin Mannheim
Contact Michael Behnes, Prof. Dr.
Phone +49 621 383 6239
Email michael.behnes@umm.de
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

The EPIC registry is an observational multicentre registry evaluating the technical feasibility of retrograde CTO-PCI using epicardial collateral connections. It will evaluate the frequency, effectiveness, safety and outcomes of patients who underwent CTO-PCI using this approach. The EPIC registry retrieves data from CTO centres across Germany.

Description:

The EPIC registry is the first German-wide observational multicentre registry evaluating the technical feasibility, clinical success and safety of retrograde CTO-PCI using epicardial collateral connections. The EPIC registry retrieves data from CTO centres across Germany. All patients will be followed-up to 30 days after inclusion.

Recruitment information / eligibility
Status Recruiting
Enrollment 500
Est. completion date December 31, 2022
Est. primary completion date December 31, 2021
Accepts healthy volunteers
Gender All
Age group N/A and older
Eligibility Inclusion Criteria:

- All patients undergoing retrograde CTO-PCI using epicardial collateral connections during daily clinical practice.

Exclusion Criteria:

- None.

Study Design

Related Conditions & MeSH terms

Intervention

Procedure:
• Retrograde Percutaneous Coronary Intervention of Chronic Total Occlusion
Retrograde CTO-PCI using epicardial collateral connections

Locations
Country Name City State
Germany University Medical Centre Mannheim Mannheim Baden Württemberg

Sponsors (2)
Lead Sponsor Collaborator
Universitätsmedizin Mannheim University Heart Center Freiburg - Bad Krozingen

Country where clinical trial is conducted

Germany, 

Outcome
Type Measure Description Time frame Safety issue
Primary Rate of technically successful retrograde CTO-PCI using epicaridal collaterals defined as the rate of successful CTO-PCI with reestablished antegrade coronary flow (thrombolysis in myocardial infarction (TIMI) flow III) with less than residual stenosis of 50%. 30 days
Secondary Rate of clinically successful retrograde CTO-PCI using epicaridal collaterals Clinical success is defined as the rate of successful CTO-PCI by technical success without MACCE and without major periprocedural complications, including pericardial tamponade and contrast induced dialysis. 30 days
Secondary Rate of failed retrograde CTO-PCI using epicaridal collaterals is defined as the rate of CTO-PCI without technical success defined as residual stenosis >50% (by visual estimation) and TIMI flow grade <3 after CTO-PCI. 30 days
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