Chronic Total Occlusion of Coronary ArteryCSINCT04650139
Coronary Interventions Ulm - Coronary Chronic Total Occlusions
An observational study of Chronic Total Occlusion of Coronary Artery and Chronic Total Occlusion, run by University Hospital Ulm at 1 site in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Chronic Total Occlusion of Coronary Artery, Chronic Total Occlusion
- What is being tested?
- PCI - percutaneous coronary intervention
- Type of treatment
- Surgery or procedure
- How many people
- 500 participants
- Where
- 1 siteGermany
- Study dates
- 1 Jan 2014to 1 Jan 2025
- How long will I take part?
- 12 Months
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: patients with CTO
Who may be able to join
- 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
Show all 9Show fewer
- Evidence of myocardial ischemia (stress ECG, scintigraphic
- Methods, magnetic resonance imaging, stress echocardiography)
- pathological intracoronary flow reserve, prognostic
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
Germany1 site, 1 recruiting
- Recruiting
University Ulm
Ulm, 89073
Bruno Correia, +4973145058, bruno.correia@uniklinik-ulm.de
About this study
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.
- Being tested
- PCI - percutaneous coronary intervention
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PCI - percutaneous coronary interventionProcedure or surgery
Also called drug eluting stents, Scaffolds, drug eluting ballons
percutaneous coronary intervention
| Study group | Role | What they receive |
|---|---|---|
| successful CTO | Not described Receives: Procedure: PCI - percutaneous coronary intervention | |
| non- successful CTO | Not described Receives: Procedure: PCI - percutaneous coronary intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
MACE
major adverse cardiac event
Measured: 1 year
Secondary outcomes (1)
TLR
target lesion revascularization
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Dec 2020
- Study start1 Jan 2014
- Primary completion1 Jan 2024 (estimated)
- Study completion1 Jan 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Total Occlusion of Coronary ArteryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 500 participants (estimated)
- Target duration
- 12 Months
Sponsor and investigators
- Lead sponsor
- University Hospital Ulm
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Bruno Correia, University Hospital Ulm
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04650139
- Sponsor's protocol ID
- 0925-0586
- Acronym
- CSI
- Status last verified
- Nov 2020
- First submitted
- 24 Nov 2020
- Last updated
- 2 Dec 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 2 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Coronary Interventions Ulm - Coronary Chronic Total Occlusions
- ClinicalTrials.gov ID
- NCT04650139
- Acronym / sponsor ID
- CSI / 0925-0586
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- University Hospital UlmUniversity, hospital or other
- Study start
- 1 Jan 2014 (actual)
- Primary completion
- 1 Jan 2024 (estimated)
- Study completion
- 1 Jan 2025 (estimated)
- First posted
- 2 Dec 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 12 Months
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| successful CTO | – | Procedure: PCI - percutaneous coronary intervention |
| non- successful CTO | – | Procedure: PCI - percutaneous coronary intervention |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- patients with CTO
Key inclusion criteria (9 listed)
- Patients over 18 years
- Coronary intervention in chronic coronary artery occlusion
- Occlusion > 3 months
- Indication for PTCA or recanalization according to guidlines
- Symptoms of the patient
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PCI - percutaneous coronary interventionAlso: drug eluting stents, Scaffolds, drug eluting ballonspercutaneous coronary intervention | Procedure or surgery | non- successful CTO, successful CTO |
Primary outcome
MACE
Time frame: 1 year
major adverse cardiac event
1 secondary outcome
TLR
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Dec 2020.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Total Occlusion of Coronary Artery and Chronic Total Occlusion, run by University Hospital Ulm at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 2 Dec 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
MACE (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Dec 2020.