NCT04533633

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
500

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2018

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2018

Completed
2.6 years until next milestone

First Submitted

Initial submission to the registry

August 23, 2020

Completed
8 days until next milestone

First Posted

Study publicly available on registry

August 31, 2020

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2021

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2022

Completed
Last Updated

September 1, 2020

Status Verified

August 1, 2020

Enrollment Period

4 years

First QC Date

August 23, 2020

Last Update Submit

August 29, 2020

Conditions

Coronary Artery DiseaseChronic Total OcclusionPercutaneous Coronary Intervention

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (2)

  • Rate of clinically successful retrograde CTO-PCI using epicaridal collaterals

    30 days

  • Rate of failed retrograde CTO-PCI using epicaridal collaterals

    30 days

Interventions

Retrograde Percutaneous Coronary Intervention of Chronic Total OcclusionPROCEDURE

Retrograde CTO-PCI using epicardial collateral connections

Eligibility Criteria

Sexall
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

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

You may not qualify if:

  • None.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Medical Centre Mannheim

Mannheim, Baden-Wurttemberg, 76149, Germany

RECRUITING

MeSH Terms

Conditions

Coronary Artery Disease

Condition Hierarchy (Ancestors)

Coronary DiseaseMyocardial IschemiaHeart DiseasesCardiovascular DiseasesArteriosclerosisArterial Occlusive DiseasesVascular Diseases

Central Study Contacts

Michael Behnes, Prof. Dr.

CONTACT

+49 621 383 6239michael.behnes@umm.de

Kambis Mashayekhi, Dr.

CONTACT

+49 7633 402 2100Kambis.Mashayekhi@universitaets-herzzentrum.de

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

August 23, 2020

First Posted

August 31, 2020

Study Start

January 1, 2018

Primary Completion

December 31, 2021

Study Completion

December 31, 2022

Last Updated

September 1, 2020

Record last verified: 2020-08

Locations

DE(1)