Coronary Artery DiseaseNCT04011527
The Prospective Segeberg Registry for Rotational Atherectomy in Coronary Lesion/s
An observational study of Coronary Artery Disease, run by Segeberger Kliniken GmbH at 1 site in Germany.
Trial summary
A Prospective Follow-up Assessment in Bad Segeberg with Patients undergoing a Rotational Atherectomy in Coronary Lesion/s Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Coronary Artery Disease
- What is being tested?
- Rotational Atherectomy in Coronary Lesion/s
- Type of treatment
- Surgery or procedure
- How many people
- 1,500 participants
- Where
- 1 siteGermany
- Study dates
- 25 Nov 2002to 31 Dec 2032
- How long will I take part?
- 2 Years
- 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 artery disease undergoing a rotational atherectomy in coronary lesion/s
Who may be able to join
- All patients undergoing a rotational atherectomy of coronary lesion/s
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.
Germany1 site, 1 recruiting
- Recruiting
Herzzentrum Segeberger Kliniken GmbH
Bad Segeberg, 23795
Gert Richardt, MD, +49 4551 802 4801, gert.richardt@segebergerkliniken.de
About this study
Official title: A Prospective Follow-up Assessment in Bad Segeberg With Patients Undergoing a Rotational Atherectomy in Coronary Lesion/s
A Prospective Follow-up Assessment in Bad Segeberg with Patients undergoing a Rotational Atherectomy in Coronary Lesion/s
Read the detailed description
A prospective single center registry including all patients treated with Rotational Atherectomy in 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 Artery Disease
- Being tested
- Rotational Atherectomy in Coronary Lesion/s
- Keywords
- Calcified coronary artery lesions
- Medical subject headings
- Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Rotational Atherectomy in Coronary Lesion/sProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| Patients with Coronary Artery Disease | Patients with Coronary Artery Disease undergoing a Rotational Atherectomy in Coronary Lesion/s Receives: Procedure: Rotational Atherectomy in Coronary Lesion/s |
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 posted8 Jul 2019
- Study start25 Nov 2002
- 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.
- Other trials for Coronary Artery DiseaseStudies 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)
- Target duration
- 2 Years
Sponsor and investigators
- Lead sponsor
- Segeberger Kliniken GmbH
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Gert Richardt, Prof., MD, Study director, Herzzentrum Segeberger Kliniken GmbH
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04011527
- Sponsor's protocol ID
- SK 111 -- 168/11
- Status last verified
- Jun 2022
- First submitted
- 28 Jun 2019
- Last updated
- 6 Jun 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Jun 2022. 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 a Rotational Atherectomy in Coronary Lesion/s
- ClinicalTrials.gov ID
- NCT04011527
- Acronym / sponsor ID
- SK 111 -- 168/11
- Conditions
- Coronary Artery Disease
- Keywords
- Calcified coronary artery lesions
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 1,500 participants (estimated)
- Lead sponsor
- Segeberger Kliniken GmbHUniversity, hospital or other
- Study start
- 25 Nov 2002 (actual)
- Primary completion
- 31 Dec 2030 (estimated)
- Study completion
- 31 Dec 2032 (estimated)
- First posted
- 8 Jul 2019 (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 a Rotational Atherectomy in Coronary Lesion/s
Detailed description
A prospective single center registry including all patients treated with Rotational Atherectomy in 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
- Target follow-up
- 2 Years
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with Coronary Artery Disease | – | Procedure: Rotational Atherectomy in Coronary Lesion/sPatients with Coronary Artery Disease undergoing a Rotational Atherectomy in Coronary Lesion/s |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with coronary artery disease undergoing a rotational atherectomy in coronary lesion/s
Key inclusion criteria (1 listed)
- All patients undergoing a rotational atherectomy of coronary lesion/s
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 |
|---|---|---|
| Rotational Atherectomy in Coronary Lesion/s | Procedure or surgery | Patients with Coronary Artery Disease |
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 6 Jun 2022.
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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.
Gert Richardt, 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 Artery Disease, 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 6 Jun 2022. 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 Abdelhakim Allali, MD (+4945512802 ext. 4801, allali.abdelhakim@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?
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 6 Jun 2022.