Coronary Chronic Total OcclusionsCTO RegistryNCT06957613
The Prospective Segeberg Registry for Coronary Chronic Total Occlusions (CTO)
An observational study of Coronary Chronic Total Occlusions, run by Segeberger Kliniken GmbH at 1 site in Germany.
Trial summary
A Prospective Follow-up Assessment in Bad Segeberg with Patients undergoing Recanalization for Coronary Chronic Total Occlusion Lesion/s Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Coronary Chronic Total Occlusions
- What is being tested?
- Revascularization/Conservative management
- Type of treatment
- Surgery or procedure
- How many people
- 1,500 participants
- Where
- 1 siteGermany
- Study dates
- 1 Jul 2017to 31 Dec 2032
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with coronary chronic total occlusions undergoing recanalization vie percutaneous coronary interventions
Who may be able to join
- Patients with coronary chronic total occlusions undergoing recanalization via percutaneous coronary interventions
Who cannot join
- None
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Stephan Fichtlscherer, Prof., MD contact
Germany1 site, 1 recruiting
- Recruiting
Herzzentrum Segeberger Kliniken GmbH
Bad Segeberg, Schleswig-Holstein, 23795
Holger Nef, Prof., MD, +4945512802 ext. 9890, holger.nef@me.com
About this study
Official title: A Prospective Follow-up Assessment in Bad Segeberg With Patients Undergoing Recanalization of Coronary Lesions With Chronic Total Occlusion
A Prospective Follow-up Assessment in Bad Segeberg with Patients undergoing Recanalization for Coronary Chronic Total Occlusion Lesion/s
Read the detailed description
A prospective single center registry including all patients treated for Chronic Total Occlusion Coronary Lesion/s at the Heart Center, Bad Segeberg, Germany. Patients undergo a routine clinical follow-up schedule, including a long-term follow-up.
- Conditions
- Coronary Chronic Total Occlusions
- Being tested
- Revascularization/Conservative management
- Keywords
- Chronic Total Occlusion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Revascularization/Conservative managementProcedure or surgery
Percutaneous Transluminal Angioplasty of Coronary Chronic Total Occlusions via Dedicated Drug Eluting Stents and/or Balloons.
| Study group | Role | What they receive |
|---|---|---|
| Patients with Coronary Chronic Total Occlusions | Patients undergoing Recanalization for Coronary Chronic Total Occlusions Receives: Procedure: Revascularization/Conservative management |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of in-hospital and long-term cardiovascular adverse events in percent
Peri-procedural events and in-hospital cardiovascular events and long-term cardiovascular events (bleeding, peripheral and coronary vascular complication, stroke, myocardial infarction, stent thrombosis, revascularization, death)
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 May 2025
- Study start1 Jul 2017
- Primary completion31 Dec 2030 (estimated)
- Study completion31 Dec 2032 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Coronary Chronic Total OcclusionsStudies 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
- 1,500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Segeberger Kliniken GmbH
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Holger Nef, Prof., MD, Study director, Herzzentrum Segeberger Kliniken GmbH
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06957613
- Sponsor's protocol ID
- SK 112 - 168/11
- Acronym
- CTO Registry
- Status last verified
- Apr 2025
- First submitted
- 26 Apr 2025
- Last updated
- 4 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Amoey D, Elbasha K, Samy M, Landt M, Kurniadi A, Schiopu O, Allali A, Saad M, Hofmann FJ, Frank D, Toelg R, Richardt G, Fichtlscherer S, Nef H, Mankerious N. In-Hospital and One-Year Outcomes After Percutaneous Coronary Intervention for Chronic Coronary Occlusion in Octogenarians. Cardiol Ther. 2026 Oct 25. doi: 10.1007/s40119-026-00485-1. Online ahead of print.
PubMed 42927561
Study at a glance
From the registry record, last updated by the sponsor on 4 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Follow-up Assessment in Bad Segeberg With Patients Undergoing Recanalization of Coronary Lesions With Chronic Total Occlusion
- ClinicalTrials.gov ID
- NCT06957613
- Acronym / sponsor ID
- CTO Registry / SK 112 - 168/11
- Conditions
- Coronary Chronic Total Occlusions
- Keywords
- Chronic Total Occlusion
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 1,500 participants (estimated)
- Lead sponsor
- Segeberger Kliniken GmbHUniversity, hospital or other
- Study start
- 1 Jul 2017 (actual)
- Primary completion
- 31 Dec 2030 (estimated)
- Study completion
- 31 Dec 2032 (estimated)
- First posted
- 4 May 2025 (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.
A Prospective Follow-up Assessment in Bad Segeberg with Patients undergoing Recanalization for Coronary Chronic Total Occlusion Lesion/s
Detailed description
A prospective single center registry including all patients treated for Chronic Total Occlusion Coronary Lesion/s at the Heart Center, Bad Segeberg, Germany. Patients undergo a routine clinical follow-up schedule, including a long-term follow-up.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with Coronary Chronic Total Occlusions | – | Procedure: Revascularization/Conservative managementPatients undergoing Recanalization for Coronary Chronic Total Occlusions |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with coronary chronic total occlusions undergoing recanalization vie percutaneous coronary interventions
Key inclusion criteria (1 listed)
- Patients with coronary chronic total occlusions undergoing recanalization via percutaneous coronary interventions
Key exclusion criteria (1 listed)
- None
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 |
|---|---|---|
| Revascularization/Conservative managementPercutaneous Transluminal Angioplasty of Coronary Chronic Total Occlusions via Dedicated Drug Eluting Stents and/or Balloons. | Procedure or surgery | Patients with Coronary Chronic Total Occlusions |
Primary outcome
Rate of in-hospital and long-term cardiovascular adverse events in percent
Time frame: 2 years
Peri-procedural events and in-hospital cardiovascular events and long-term cardiovascular events (bleeding, peripheral and coronary vascular complication, stroke, myocardial infarction, stent thrombosis, revascularization, death)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 May 2025.
- Derived from this study: PubMed 42927561Amoey D, Elbasha K, Samy M, Landt M, Kurniadi A, Schiopu O, Allali A, Saad M, Hofmann FJ, Frank D, Toelg R, Richardt G, Fichtlscherer S, Nef H, Mankerious N. In-Hospital and One-Year Outcomes After Percutaneous Coronary Intervention for Chronic Coronary Occlusion in Octogenarians. Cardiol Ther. 2026 Oct 25. doi: 10.1007/s40119-026-00485-1. Online ahead of print.
- Individual participant dataSharing planned: No
Related trials for Coronary Chronic Total Occlusions
Not yet recruitingObservational study
Relationship Between Frontal QRS-T Angle and Collateral Circulation in Coronary Artery Chronic Total Occlusion
Chronic Total Occlusion (CTO), Frontal QRS-T Angle
Active, not recruiting
To Evaluate Whether IVUS-guided Drug-eluting Stent (DES) Implantation Leads to Better Clinical Outcomes Compared to Conventional Angiography in the Treatment of Chronic Complete Occlusion (CTO) Disease.
Chronic Total Occlusion of Coronary Artery
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Real-World Outcomes of Drug-Coated Balloon Angioplasty in Coronary Artery Disease
Coronary Artery Disease
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Predicting Functional Recovery After Coronary Chronic Total Occlusion Revascularization
Chronic Total Occlusions of Coronary Arteries, Stress Echocardiography (SE)
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TRIO CTO (Taiwan Research Initiative on Coronary Total Occlusion)
Chronic Total Occlusion (CTO)
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.
Stephan Fichtlscherer, Prof., MD contact
Holger Nef, Prof., MD study director
Herzzentrum Segeberger Kliniken GmbH
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 Coronary Chronic Total Occlusions, run by Segeberger Kliniken GmbH 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 1 inclusion and 1 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: looking for participants now, as of the sponsor's last update on 4 May 2025. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Nader Mankerious, MD (+4945512802 ext. 9491, nader.mankerious@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of in-hospital and long-term cardiovascular adverse events in percent (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06957613, which also lists 1 linked publication.
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 4 May 2025.