Coronary Artery DiseaseNCT04047368
Comparison of Coronary Lithoplasty and Rotablation
A study testing Rotablation and Coronary Lithoplasty in people with Coronary Artery Disease and Calcified Atheroma, run by University of Giessen at 1 site in Germany.
Trial summary
This study compares a new method of treating severely calcified coronary lesions, the intracoronary lithoplasty, with the current gold standard, the rotablation. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coronary Artery Disease, Calcified Atheroma
- What is being tested?
- Rotablation and Coronary Lithoplasty
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteGermany
- Study dates
- 28 Jun 2019to 28 Jun 2022
- Phase
- Interventional
- 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
Who may be able to join
- Age>18 yrs
- Stable coronary heart disease or acute coronary syndromes
- Single or multi vessel disease. Vessel is defined as, left anterior descending, left circumflex, and right coronary arteries. Any branch within the vessel is considered part of the vessel.
- Written informed consent was obtained before the procedure
- Severely calcified coronary lesion with indication for rotablation
Who cannot join
- Known renal insufficiency (serum creatinine clearance <30ml/min/1.73m² or receiving dialysis)
- Known allergy against protocol-required medications including ASS, prasugrel, ticagrelor, clopidogrel, heparin. History of bleeding diathesis or known coagulopathy
- Cardiogenic shock
- Lesion length > 32mm
- Bifurcation lesions requiring 2-Stent-Strategies
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of Coronary Lithoplasty and Rotablation for the Interventional Treatment of Severely Calcified Coronary Stenoses - ROTA.Shock-Trial
This study compares a new method of treating severely calcified coronary lesions, the intracoronary lithoplasty, with the current gold standard, the rotablation.
Read the detailed description
Severe coronary calcification is still a challenge for percutaneous coronary intervention (PCI). Reduction of the calcified plaque mass is necessary to achieve adequate stent expansion during further course. Rotablation has been the only reliable option to treat extremely calcified coronary lesions for a long time. Coronary lithoplasty has been recently introduced as a new promising treatment option in this special subset. It provides the unique opportunity to break severely calcified plaque structures even inside deeper layers of the vessel wall. Aim of this study is to compare rotablation and coronary lithotripsy for treatment of severely calcified coronary lesions. Plaque structure, plaque volume, as well as lumen diameters will be analyzed by optical coherence tomography (OCT) before and after debulking, as well as after stent implantation.
- Conditions
- Coronary Artery Disease, Calcified Atheroma
- Being tested
- Rotablation, Coronary Lithoplasty
- Keywords
- Percutaneous coronary intervention, Rotablation, Coronary lithoplasty, Optical coherence tomography
- 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.
RotablationProcedure or surgery
Percutaneous Coronary Intervention using Rotablation
Coronary LithoplastyProcedure or surgery
Percutaneous Coronary Intervention using Lithoplasty
| Study group | Role | What they receive |
|---|---|---|
| Rotablation | Active comparator | Not described Receives: Procedure: Rotablation |
| Coronary Lithoplasty | Experimental | Not described Receives: Procedure: Coronary Lithoplasty |
What is being measured
The primary outcome is the main question the study is designed to answer.
Minimal Stent Area (End of the Procedure)
Measured: 0 days
Secondary outcomes (7)
Minimal/Mean/Maximal Stent Diameter
Measured: 0 days
Minimal/Mean/Maximal Lumen area
Measured: 0 days
Minimal/Mean/Maximal Lumen diameter
Measured: 0 days
Mean/Maximal Stent area
Measured: 0 days
Incidence of target lesion failure
Measured: 0 months; 1 month; 6 months
Incidence of target vessel failure
Measured: 0 months; 1 month; 6 months
MACE rate
Measured: 0 months; 1 month; 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Aug 2019
- Study start28 Jun 2019
- Primary completion28 Jun 2021
- Study completion28 Jun 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Giessen
- Sponsor type
- University, hospital or other
- Collaborators
- Else Kröner Fresenius Foundation
- Responsible party
- Sponsor
- Investigators
- Florian Blachutzik, Dr., Principal investigator, University of Giessen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04047368
- Sponsor's protocol ID
- ROTA.shock
- Status last verified
- Nov 2023
- First submitted
- 22 Jul 2019
- Last updated
- 1 Dec 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Blachutzik F, Meier S, Blachutzik M, Schlattner S, Gori T, Ullrich-Daub H, Gaede L, Achenbach S, Mollmann H, Chitic B, Aksoy A, Nickenig G, Weferling M, Dorr O, Boeder N, Bayer M, Hamm C, Nef H; ROTA.shock Investigators. Comparison of interventional treatment options for coronary calcified nodules: A sub-analysis of the ROTA.shock trial. Cardiovasc Revasc Med. 2024 Nov;68:37-42. doi: 10.1016/j.carrev.2024.05.030. Epub 2024 May 22.
PubMed 38796321Blachutzik F, Meier S, Weissner M, Schlattner S, Gori T, Ullrich-Daub H, Gaede L, Achenbach S, Mollmann H, Chitic B, Aksoy A, Nickenig G, Weferling M, Dorr O, Boeder N, Bayer M, Elsasser A, Hamm C, Nef H; ROTA.Shock Investigators. Comparison of Coronary Intravascular Lithotripsy and Rotational Atherectomy in the Modification of Severely Calcified Stenoses. Am J Cardiol. 2023 Jun 15;197:93-100. doi: 10.1016/j.amjcard.2023.02.028. Epub 2023 Apr 2.
PubMed 37012181
Study at a glance
From the registry record, last updated by the sponsor on 1 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Coronary Lithoplasty and Rotablation for the Interventional Treatment of Severely Calcified Coronary Stenoses - ROTA.Shock-Trial
- ClinicalTrials.gov ID
- NCT04047368
- Acronym / sponsor ID
- ROTA.shock
- Conditions
- Coronary Artery Disease, Calcified Atheroma
- Keywords
- Percutaneous coronary intervention, Rotablation, Coronary lithoplasty, Optical coherence tomography
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- University of GiessenUniversity, hospital or other
- Collaborators
- Else Kröner Fresenius Foundation
- Study start
- 28 Jun 2019 (actual)
- Primary completion
- 28 Jun 2021 (actual)
- Study completion
- 28 Jun 2022 (actual)
- First posted
- 6 Aug 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.
This study compares a new method of treating severely calcified coronary lesions, the intracoronary lithoplasty, with the current gold standard, the rotablation.
Detailed description
Severe coronary calcification is still a challenge for percutaneous coronary intervention (PCI). Reduction of the calcified plaque mass is necessary to achieve adequate stent expansion during further course. Rotablation has been the only reliable option to treat extremely calcified coronary lesions for a long time. Coronary lithoplasty has been recently introduced as a new promising treatment option in this special subset. It provides the unique opportunity to break severely calcified plaque structures even inside deeper layers of the vessel wall. Aim of this study is to compare rotablation and coronary lithotripsy for treatment of severely calcified coronary lesions. Plaque structure, plaque volume, as well as lumen diameters will be analyzed by optical coherence tomography (OCT) before and after debulking, as well as after stent implantation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Rotablation | Active comparator | Procedure: Rotablation |
| Coronary Lithoplasty | Experimental | Procedure: Coronary Lithoplasty |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age>18 yrs
- Stable coronary heart disease or acute coronary syndromes
- Single or multi vessel disease. Vessel is defined as, left anterior descending, left circumflex, and right coronary arteries. Any branch within the vessel is considered part of the vessel.
- Written informed consent was obtained before the procedure
- Severely calcified coronary lesion with indication for rotablation
Key exclusion criteria (5 listed)
- Known renal insufficiency (serum creatinine clearance <30ml/min/1.73m² or receiving dialysis)
- Known allergy against protocol-required medications including ASS, prasugrel, ticagrelor, clopidogrel, heparin. History of bleeding diathesis or known coagulopathy
- Cardiogenic shock
- Lesion length > 32mm
- Bifurcation lesions requiring 2-Stent-Strategies
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 |
|---|---|---|
| RotablationPercutaneous Coronary Intervention using Rotablation | Procedure or surgery | Rotablation |
| Coronary LithoplastyPercutaneous Coronary Intervention using Lithoplasty | Procedure or surgery | Coronary Lithoplasty |
Primary outcome
Minimal Stent Area (End of the Procedure)
Time frame: 0 days
7 secondary outcomes
Minimal/Mean/Maximal Stent Diameter
Time frame: 0 days
Minimal/Mean/Maximal Lumen area
Time frame: 0 days
Minimal/Mean/Maximal Lumen diameter
Time frame: 0 days
Mean/Maximal Stent area
Time frame: 0 days
Incidence of target lesion failure
Time frame: 0 months; 1 month; 6 months
Incidence of target vessel failure
Time frame: 0 months; 1 month; 6 months
MACE rate
Time frame: 0 months; 1 month; 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Dec 2023.
- Derived from this study: PubMed 38796321Blachutzik F, Meier S, Blachutzik M, Schlattner S, Gori T, Ullrich-Daub H, Gaede L, Achenbach S, Mollmann H, Chitic B, Aksoy A, Nickenig G, Weferling M, Dorr O, Boeder N, Bayer M, Hamm C, Nef H; ROTA.shock Investigators. Comparison of interventional treatment options for coronary calcified nodules: A sub-analysis of the ROTA.shock trial. Cardiovasc Revasc Med. 2024 Nov;68:37-42. doi: 10.1016/j.carrev.2024.05.030. Epub 2024 May 22.
- Derived from this study: PubMed 37012181Blachutzik F, Meier S, Weissner M, Schlattner S, Gori T, Ullrich-Daub H, Gaede L, Achenbach S, Mollmann H, Chitic B, Aksoy A, Nickenig G, Weferling M, Dorr O, Boeder N, Bayer M, Elsasser A, Hamm C, Nef H; ROTA.Shock Investigators. Comparison of Coronary Intravascular Lithotripsy and Rotational Atherectomy in the Modification of Severely Calcified Stenoses. Am J Cardiol. 2023 Jun 15;197:93-100. doi: 10.1016/j.amjcard.2023.02.028. Epub 2023 Apr 2.
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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.
Florian Blachutzik, Dr. principal investigator
University of Giessen
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Rotablation and Coronary Lithoplasty in people with Coronary Artery Disease and Calcified Atheroma, run by University of Giessen 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 5 inclusion and 5 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: finished, as of the sponsor's last update on 1 Dec 2023. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Minimal Stent Area (End of the Procedure) (time frame: 0 days). 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 NCT04047368, which also lists 2 linked publications.
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 1 Dec 2023.