German Epicardial Collateral CTO Registry

• Conditions: Percutaneous Coronary Intervention; Coronary Artery Disease; Chronic Total Occlusion

• Registration Number: NCT04533633
• Lead Sponsor: Universitätsmedizin Mannheim

Brief 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.

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.

Study Timeline

• Study Start: 2018-01-01
• Status Verified: 2020-08
• Study First Submitted: 2020-08-23
• Study First Submitted QC: 2020-08-26
• Last Update Submitted: 2020-08-29
• Study First Posted: 2020-08-31
• Last Update Posted: 2020-09-01
• Primary Completion: 2021-12-31
• Study Completion: 2022-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 500

Inclusion Criteria

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

Exclusion Criteria

• None.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

University Medical Centre Mannheim; 🇩🇪 Mannheim, Baden Württemberg, Germany