German Epicardial Collateral CTO Registry (EPIC)

August 29, 2020 updated by: Michael Behnes, Universitätsmedizin Mannheim

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Anticipated)

500

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Germany
    • Baden Württemberg
      • Mannheim, Baden Württemberg, Germany, 76149
        • Recruiting
        • University Medical Centre Mannheim
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

EPIC will observationally evaluate all patients undergoing retrograde CTO-PCI using epicardial collateral connections during daily clinical practice from German CTO centres.

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • None.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Rate of technically successful retrograde CTO-PCI using epicaridal collaterals
Time Frame: 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%.
30 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Rate of clinically successful retrograde CTO-PCI using epicaridal collaterals
Time Frame: 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.
30 days
Rate of failed retrograde CTO-PCI using epicaridal collaterals
Time Frame: 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.
30 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Universitätsmedizin Mannheim

Collaborators

University Heart Center Freiburg - Bad Krozingen

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2018

Primary Completion (Anticipated)

December 31, 2021

Study Completion (Anticipated)

December 31, 2022

Study Registration Dates

First Submitted

August 23, 2020

First Submitted That Met QC Criteria

August 26, 2020

First Posted (Actual)

August 31, 2020

Study Record Updates

Last Update Posted (Actual)

September 1, 2020

Last Update Submitted That Met QC Criteria

August 29, 2020

Last Verified

August 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2017-838R-MA

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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