Coronary Interventions Ulm - Coronary Chronic Total Occlusions (CSI)

The aim of the proposed project is to provide the long-term results after a recanalization attempt of chronically occluded coronary arteries.

To investigate recanalization attempt of chronically occluded coronary arteries at the Ulm University Hospital. As shown, it is known that successful recanalization of a chronic occlusion is associated with a lower event rate (reduced mortality and the need for operative myocardial revascularization) compared to unsuccessful recanalization (drug therapy). The standard in the therapy of successfully recanalized chronic occlusions is the use of drug-releasing vascular supports.

Study Overview

• Status: Recruiting
• Conditions: Chronic Total Occlusion; Chronic Total Occlusion of Coronary Artery
• Intervention / Treatment: Procedure: PCI - percutaneous coronary intervention

• Study Type: Observational
• Enrollment (Anticipated): 500

Contacts and Locations

Study Locations

• Germany
  • Ulm, Germany, 89073
    • Recruiting
    • University Ulm
    • Contact: Bruno Correia; Phone Number: +4973145058; Email: bruno.correia@uniklinik-ulm.de

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

patients with CTO

Description

Inclusion Criteria:

• Patients over 18 years

Coronary intervention in chronic coronary artery occlusion

Occlusion > 3 months

Indication for PTCA or recanalization according to guidlines

such as:

Symptoms of the patient

Evidence of myocardial ischemia (stress ECG, scintigraphic

Methods, magnetic resonance imaging, stress echocardiography)

pathological intracoronary flow reserve, prognostic

Exclusion Criteria:

• No chronic occlusion,
• Contraindication to anti-platelet therapy

Acetylsalicylic acid plus clopidogrel for at least 3 months such as e.g.

with florid gastrointestinal ulcer disease,

History of hemorrhagic stroke

or urgent non-postponable surgical intervention.

Basic disease with a life expectancy of less than 12 months (here as a rule

no indication for PTCA or reopening available)

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
successful CTO	Procedure: PCI - percutaneous coronary intervention; percutaneous coronary intervention; Other Names: drug eluting stents, Scaffolds, drug eluting ballons
non- successful CTO	Procedure: PCI - percutaneous coronary intervention; percutaneous coronary intervention; Other Names: drug eluting stents, Scaffolds, drug eluting ballons

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
MACE	major adverse cardiac event	1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
TLR	target lesion revascularization	1 year

Collaborators and Investigators

• Sponsor: University Hospital Ulm

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2014
• Primary Completion (Anticipated): January 1, 2024
• Study Completion (Anticipated): January 1, 2025

Study Registration Dates

• First Submitted: November 24, 2020
• First Submitted That Met QC Criteria: November 24, 2020
• First Posted (Actual): December 2, 2020

Study Record Updates

• Last Update Posted (Actual): December 2, 2020
• Last Update Submitted That Met QC Criteria: November 24, 2020
• Last Verified: November 1, 2020

More Information

Terms related to this study

• Other Study ID Numbers: 0925-0586

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: Yes
• product manufactured in and exported from the U.S.: No