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
• Status: Recruiting
• 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
• 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
• 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.

Related Conditions & MeSH terms

• Chronic Total Occlusion
• Coronary Artery Disease
• Percutaneous Coronary Intervention

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