German Epicardial Collateral CTO Registry

NCT04533633 — Unknown, 500 participants, Universitätsmedizin Mannheim

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

Registry	NCT04533633, acronym EPIC
Status	Unknown
Study type	Observational
Enrollment	500 (Estimated)
Sponsor	Universitätsmedizin Mannheim (Other); collaborators: University Heart Center Freiburg - Bad Krozingen
Conditions	Coronary Artery Disease, Chronic Total Occlusion, Percutaneous Coronary Intervention
Interventions	Retrograde Percutaneous Coronary Intervention of Chronic Total Occlusion (Procedure)
Dates	start 2018-01-01, primary completion 2021-12-31 (estimated), completion 2022-12-31 (estimated), first posted 2020-08-31, last updated 2020-09-01
Locations	1 site in Germany

-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.

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+Detailed 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.

+Arms and interventions

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

+Outcome measures

Primary outcomes

Rate of technically successful retrograde CTO-PCI using epicaridal collaterals [30 days]: 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%.

Secondary outcomes

Rate of clinically successful retrograde CTO-PCI using epicaridal collaterals [30 days]: 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.
Rate of failed retrograde CTO-PCI using epicaridal collaterals [30 days]: 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.

+Eligibility

Sex: All

Inclusion Criteria:

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

Exclusion Criteria:

* None.

+Locations (1)

Facility	City	Country	Status
University Medical Centre Mannheim	Mannheim, Baden-Wurttemberg	Germany	Recruiting