Coronary Artery DiseaseNCT04014595
PREPARE-CALC-COMBO: Severely Calcified Coronary Lesions Prepared With Rotational Atherectomy and Modified Balloons
An observational study of Coronary Artery Disease, run by Segeberger Kliniken GmbH at 1 site in Germany.
Trial summary
A prospective single-arm trial of rotational atherectomy in combination with cutting balloon in severely calcified coronary lesions. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coronary Artery Disease
- What is being tested?
- Rotational atherectomy in combination with cutting balloon
- Type of treatment
- Surgery or procedure
- How many people
- 100 participants
- Where
- 1 siteGermany
- Study dates
- 1 Jan 2019to 31 Jul 2025
- How long will I take part?
- 2 Years
- 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
- No healthy volunteers
- Adult, Older adult
Study population: Patients with coronary artery disease subjected to percutaneous revascularization of the native coronary arteries and fullfilling all of the inclusion criteria and none of the exclusion criteria.
Who may be able to join
- Clinical inclusion criteria
- Age above 18 years and consentable
- Angiographically proven coronary artery disease
- Anginal symptoms and/or reproducible ischemia in the target area by ECG, functional stress testing or fractional flow reserve
- Written informed consent
- Angiographic inclusion criteria
Show all 10Show fewer
- De-novo lesion in a native coronary artery
- Target reference vessel diameter between 2.25 and 4.0 mm by visual estimation
- Luminal diameter reduction of 50-100% by visual estimation
- Severe calcification of the target lesion (for definition see appendix)
Who cannot join
- Clinical exclusion criteria
- Myocardial infarction (within 1 week)
- Decompensated heart failure
- Limited long term prognosis due to other conditions
- Angiographic exclusion criteria
- Target lesion is in a coronary artery bypass graft
- Target lesion is an in-stent restenosis
- Target vessel thrombus
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Evaluation of a Strategy to PREPARE Severely CALCified Coronary Lesions With a Combination Of Rotational Atherectomy and Modified BallOons Trial (PREPARE-CALC- COMBO)
A prospective single-arm trial of rotational atherectomy in combination with cutting balloon in severely calcified coronary lesions.
Read the detailed description
A prospective single-arm trial to evaluate the acute and long term efficacy of a combined strategy of lesion preparation with rotational atherectomy followed by cutting balloon and by hybrid sirolimus-eluting stent implantation in an angiographically well-defined group of patients with severely calcified coronary lesions.
- Conditions
- Coronary Artery Disease
- Being tested
- Rotational atherectomy in combination with cutting balloon
- Keywords
- Calcified coronary 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 combination with cutting balloonProcedure or surgery
Treatment of severely calcified coronary lesion using rotational atherectomy followed by balloon angioplasty using a cutting balloon and Implantation of the hybrid sirolimus-eluting stent.
| Study group | Role | What they receive |
|---|---|---|
| Rotational atherectomy + Cutting Balloon | Rotational atherectomy in combination with cutting balloon in severely calcified coronary lesions Receives: Procedure: Rotational atherectomy in combination with cutting balloon |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary endpoint: Numerical in-stent acute lumen gain in mm
The main angiographic endpoint will be in-stent acute lumen gain defined as minimal lumen diameter (MLD) in stent at the end of the index procedure minus baseline MLD.
Measured: At the end of the index procedure
Co-primary OCT endpoint: Ratio of stent expansion index (SEI)
The main OCT endpoint will be stent expansion index (SEI), defined as minimum stent area divided by mean reference area in optical coherence tomography (OCT) quantitative analysis at the end of the index procedure
Measured: At the end of the index procedure
Secondary outcomes (10)
Numerical in-stent late lumen loss at 9 month follow-up angiography in mm
In-stent late lumen loss at 9 month follow-up angiography defined as the difference between the postprocedure in-stent minimal lumen diameter (MLD)and the in-stent MLD at 9-month followup angiography will be adopted as a co-primary endpoint.
Measured: 9 months follow-up
Rate of angiographic success in percent
'Angiographic Success' defined as successful stent delivery and expansion with attainment of < 20% in-stent residual stenosis of the target lesion in the presence of TIMI 3 flow.
Measured: Peri-procedural
Rate of strategy success in percent
'Strategy Success' defined as successful stent delivery and expansion with attainment of < 20% in-stent residual stenosis of the target lesion in the presence of TIMI 3 flow without stent failure.
Measured: Peri-procedural
Rate of target vessel failure in percent
Target vessel failure (TVF) defined as a composite of cardiac death, target vessel related myocardial infarction and clinically driven target vessel revascularization at 9 months, 1 and 2 years.
Measured: 9 months, 1 and 2 years follow-up
Rate of in-segment binary restenosis at 9 months in percent
In-segment binary restenosis at 9 months
Measured: 9 months follow-up
Rate of stent thrombosis in percent
Stent thrombosis
Measured: 9 months, 1 and 2 years follow-up and final 5 years follow-up
Rate of peri-procedural myocardial infarction in percent
Peri-procedural myocardial infarction
Measured: Peri-procedural
Rate of vessel perforation in percent
Rate of vessel perforation
Measured: Peri-procedural
Numerical procedural duration in min
Procedural duration
Measured: Peri-procedural
Numerical contrast dye amount in ml
Procedural contrast dye amount
Measured: Peri-procedural
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jul 2019
- Study start1 Jan 2019
- Primary completion31 Mar 2021
- Study completion31 Jul 2025 (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
- 100 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., Study chair, Herzzentrum Segeberger Kliniken GmbH
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04014595
- Sponsor's protocol ID
- SK 110 -- 168/11
- Status last verified
- Jun 2022
- First submitted
- 28 Jun 2019
- Last updated
- 8 Jun 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Evaluation of a Strategy to PREPARE Severely CALCified Coronary Lesions With a Combination Of Rotational Atherectomy and Modified BallOons Trial (PREPARE-CALC- COMBO)
- ClinicalTrials.gov ID
- NCT04014595
- Acronym / sponsor ID
- SK 110 -- 168/11
- Conditions
- Coronary Artery Disease
- Keywords
- Calcified coronary lesions
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Segeberger Kliniken GmbHUniversity, hospital or other
- Study start
- 1 Jan 2019 (actual)
- Primary completion
- 31 Mar 2021 (actual)
- Study completion
- 31 Jul 2025 (estimated)
- First posted
- 10 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 single-arm trial of rotational atherectomy in combination with cutting balloon in severely calcified coronary lesions.
Detailed description
A prospective single-arm trial to evaluate the acute and long term efficacy of a combined strategy of lesion preparation with rotational atherectomy followed by cutting balloon and by hybrid sirolimus-eluting stent implantation in an angiographically well-defined group of patients with severely calcified coronary lesions.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 2 Years
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Rotational atherectomy + Cutting Balloon | – | Procedure: Rotational atherectomy in combination with cutting balloonRotational atherectomy in combination with cutting balloon in severely calcified coronary lesions |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with coronary artery disease subjected to percutaneous revascularization of the native coronary arteries and fullfilling all of the inclusion criteria and none of the exclusion criteria.
Key inclusion criteria (10 listed)
- Clinical inclusion criteria
- Age above 18 years and consentable
- Angiographically proven coronary artery disease
- Anginal symptoms and/or reproducible ischemia in the target area by ECG, functional stress testing or fractional flow reserve
- Written informed consent
Key exclusion criteria (8 listed)
- Clinical exclusion criteria
- Myocardial infarction (within 1 week)
- Decompensated heart failure
- Limited long term prognosis due to other conditions
- Angiographic exclusion criteria
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 combination with cutting balloonTreatment of severely calcified coronary lesion using rotational atherectomy followed by balloon angioplasty using a cutting balloon and Implantation of the hybrid sirolimus-eluting stent. | Procedure or surgery | Rotational atherectomy + Cutting Balloon |
Primary outcome
Primary endpoint: Numerical in-stent acute lumen gain in mm
Time frame: At the end of the index procedure
The main angiographic endpoint will be in-stent acute lumen gain defined as minimal lumen diameter (MLD) in stent at the end of the index procedure minus baseline MLD.
Co-primary OCT endpoint: Ratio of stent expansion index (SEI)
Time frame: At the end of the index procedure
The main OCT endpoint will be stent expansion index (SEI), defined as minimum stent area divided by mean reference area in optical coherence tomography (OCT) quantitative analysis at the end of the index procedure
10 secondary outcomes
Numerical in-stent late lumen loss at 9 month follow-up angiography in mm
Time frame: 9 months follow-up
Rate of angiographic success in percent
Time frame: Peri-procedural
Rate of strategy success in percent
Time frame: Peri-procedural
Rate of target vessel failure in percent
Time frame: 9 months, 1 and 2 years follow-up
Rate of in-segment binary restenosis at 9 months in percent
Time frame: 9 months follow-up
Rate of stent thrombosis in percent
Time frame: 9 months, 1 and 2 years follow-up and final 5 years follow-up
Rate of peri-procedural myocardial infarction in percent
Time frame: Peri-procedural
Rate of vessel perforation in percent
Time frame: Peri-procedural
Numerical procedural duration in min
Time frame: Peri-procedural
Numerical contrast dye amount in ml
Time frame: Peri-procedural
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 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. This study is not recruiting at the moment.
Gert Richardt, Prof. study chair
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 10 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 8 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Primary endpoint: Numerical in-stent acute lumen gain in mm (time frame: At the end of the index procedure). The study lists 2 primary outcomes in all. 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 8 Jun 2022.