CClinicalTrials.gg
Status unknownNCT04650139CSIUpdated Dec 2, 2020

Coronary Interventions Ulm - Coronary Chronic Total Occlusions

An observational study in Chronic Total Occlusion of Coronary Artery and Chronic Total Occlusion, sponsored by University Hospital Ulm. Status unknown at 1 site in Germany. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-12-02.

Sponsored by University Hospital Ulm · Observational

The sponsor has not verified this record recently (last verified Nov 2020), so the status shown — last known as Recruiting — may be out of date.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
500
Ages
18 Years and older
Sex
All
01

Study summary

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.

02

Conditions studied

  • Chronic Total Occlusion of Coronary Artery
  • Chronic Total Occlusion
03

In context

Lead sponsor

University Hospital Ulm is the lead sponsor of 10 studies on the registry; 4 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

Study population

patients with CTO

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

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)

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Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
500 participants (estimated)
Target follow-up
12 Months
Patient registry
Yes

Groups and cohorts

  • successful CTO

    Procedure: PCI - percutaneous coronary intervention

  • non- successful CTO

    Procedure: PCI - percutaneous coronary intervention

Interventions

  • ProcedurePCI - percutaneous coronary intervention

    percutaneous coronary intervention

    Also known as: drug eluting stents, Scaffolds, drug eluting ballons

06

What researchers measure

Primary outcomes

  1. MACE

    major adverse cardiac event

    Time frame: 1 year

Secondary outcomes

  1. TLR

    target lesion revascularization

    Time frame: 1 year

07

Study locations

1 of 1 sites recruiting
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References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 2, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04650139
Lead sponsor
University Hospital Ulm
Responsible party
Bruno Correia (Investigator, University Hospital Ulm) — Principal investigator
First posted
Dec 2, 2020
Start date
Jan 1, 2014
Primary completion
Jan 1, 2024 (estimated)
Completion
Jan 1, 2025 (estimated)
Last update
Dec 2, 2020

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Nov 2020. You cannot join it, but the record below documents what was studied.

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