Coronary Atherosclerosis Due to Severely Calcified Coronary LesionPREPARE-CALCNCT02502851

The Comparison of Strategies to PREPARE Severely CALCified Coronary Lesions Trial (PREPARE-CALC)

A study testing Rotational Atherectomy and Cutting/Scoring Balloon in people with Coronary Atherosclerosis Due to Severely Calcified Coronary Lesion, run by Segeberger Kliniken GmbH at 1 site in Germany.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

The primary objective of this study is to evaluate the success of lesion preparation with either rotational atherectomy or cutting/scoring balloons as well as the long term effects of a hybrid sirolimus-eluting stent in an angiographically well-defined group of patients with complex calcified coronary lesions. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Coronary Atherosclerosis Due to Severely Calcified Coronary Lesion
What is being tested?: Rotational Atherectomy and Cutting/Scoring Balloon
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 200 participants
Where: 1 siteGermany
Study dates: Sep 2014to Oct 2019
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

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

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.

Germany1 site

Segeberger Kliniken GmbH
Bad Segeberg, Schleswig-Holstein, 23795

Other trials in Germany

About this study

Official title: The Comparison of Strategies to PREPARE Severely CALCified Coronary Lesions Trial (PREPARE-CALC): A Prospective Randomized Controlled Trial of Rotational Atherectomy Versus Cutting/Scoring Balloon in Severely Calcified Coronary Lesions

Conditions: Coronary Atherosclerosis Due to Severely Calcified Coronary Lesion
Being tested: Rotational Atherectomy, Cutting/Scoring Balloon

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Rotational AtherectomyDevice
Calcified lesion preparation using rotational atherectomy before implantation of the Orsiro drug eluting stent
Cutting/Scoring BalloonDevice
Calcified lesion preparation using cutting/scoring balloons before implantation of the Orsiro drug eluting stent

Study groups in NCT02502851
Study group	Role	What they receive
Rotational Atherectomy	Active comparator	Calcified lesion preparation using rotational atherectomy followed by implantation of the ORSIRO sirolimus-eluting stent Receives: Device: Rotational Atherectomy
Cutting/Scoring Balloon	Active comparator	Calcified lesion preparation using cutting/scoring balloon followed by implantation of the ORSIRO sirolimus-eluting stent Receives: Device: Cutting/Scoring Balloon

What is being measured

The primary outcome is the main question the study is designed to answer.

Strategy Success
The primary endpoint will be '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 crossover or stent failure
Measured: Intraprocedural
In-Stent late lumen loss at 9 months
Co-primary Endpoint: The in-stent late lumen loss at 9 months, defined as the difference between the postprocedure in-stent minimal lumen diameter (MLD) and the in-stent MLD at 9-month followup angiography.
Measured: 9 months

Secondary outcomes (7)

Target vessel failure (TVF)
Target vessel failure (TVF) defined as a composite of cardiac death, target vessel related myocardial infarction (MI; Q- or non-Q-wave) and clinically driven target vessel revascularization (TVR) at 9 months, 1 and 2 years
Measured: 9 months, 1 year, 2 years
In-segment late lumen loss at 9 months
In-segment late lumen loss (stent length + 5 mm on either side) at 9 months
Measured: 9 months
In-segment binary restenosis at 9 months
In-segment binary restenosis (diameter stenosis ≥ 50%) at 9 months
Measured: 9 months
Stent thrombosis at 9 months, 1 and 2 years
Stent thrombosis at 9 months, 1 and 2 years
Measured: 9 months, 1 and 2 years
Peri-procedural MI
Measured: within 72 hrs
Procedural duration
Measured: Intraproedural
Amount of contrast dye
Measured: Intraprocedural

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Sep 2014Oct 2019

First posted20 Jul 2015 (estimated)
Study startSep 2014
Primary completionJul 2018
Study completionOct 2019

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (13)Papers the sponsor has linked to this study.
Other trials for Coronary Atherosclerosis Due to Severely Calcified Coronary LesionStudies 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: None (open label)
Enrolment: 200 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02502851
Sponsor's protocol ID: SK 108 -- 120/14
Acronym: PREPARE-CALC
Status last verified: Mar 2020
First submitted: 13 Jul 2015
Last updated: 1 Apr 2020
Results posted: No
Data monitoring committee: Yes

Publications

Kawaguchi R, Tsurugaya H, Hoshizaki H, Toyama T, Oshima S, Taniguchi K. Impact of lesion calcification on clinical and angiographic outcome after sirolimus-eluting stent implantation in real-world patients. Cardiovasc Revasc Med. 2008 Jan-Mar;9(1):2-8. doi: 10.1016/j.carrev.2007.07.004.
PubMed 18206630
Kuriyama N, Kobayashi Y, Yamaguchi M, Shibata Y. Usefulness of rotational atherectomy in preventing polymer damage of everolimus-eluting stent in calcified coronary artery. JACC Cardiovasc Interv. 2011 May;4(5):588-9. doi: 10.1016/j.jcin.2010.11.017. No abstract available.
PubMed 21596335
Madhavan MV, Tarigopula M, Mintz GS, Maehara A, Stone GW, Genereux P. Coronary artery calcification: pathogenesis and prognostic implications. J Am Coll Cardiol. 2014 May 6;63(17):1703-14. doi: 10.1016/j.jacc.2014.01.017. Epub 2014 Feb 12.
PubMed 24530667
Abdel-Wahab M, Richardt G, Joachim Buttner H, Toelg R, Geist V, Meinertz T, Schofer J, King L, Neumann FJ, Khattab AA. High-speed rotational atherectomy before paclitaxel-eluting stent implantation in complex calcified coronary lesions: the randomized ROTAXUS (Rotational Atherectomy Prior to Taxus Stent Treatment for Complex Native Coronary Artery Disease) trial. JACC Cardiovasc Interv. 2013 Jan;6(1):10-9. doi: 10.1016/j.jcin.2012.07.017. Epub 2012 Dec 19.
PubMed 23266232
Mooney M, Teirstein P, Moses J, Turco M, Reisman M, Waksman R, Saucedo J, Mauri L, Lee D, Gershony G, Mehran R, Carlier S, Lansky A, Leon M. Final Results from the U.S. Multi-Center Trial of the AngioSculpt Scoring Balloon Catheter for the Treatment of Complex Coronary Artery Lesions. Am J Cardiol 2006;98:121.
Fonseca A, Costa Jde R Jr, Abizaid A, Feres F, Abizaid AS, Costa R, Staico R, Mattos LA, Sousa AG, Grube E, Sousa JE. Intravascular ultrasound assessment of the novel AngioSculpt scoring balloon catheter for the treatment of complex coronary lesions. J Invasive Cardiol. 2008 Jan;20(1):21-7.
PubMed 18174614
Vaquerizo B, Serra A, Miranda F, Triano JL, Sierra G, Delgado G, Puentes A, Mojal S, Brugera J. Aggressive plaque modification with rotational atherectomy and/or cutting balloon before drug-eluting stent implantation for the treatment of calcified coronary lesions. J Interv Cardiol. 2010 Jun;23(3):240-8. doi: 10.1111/j.1540-8183.2010.00547.x.
PubMed 20636844
Hamon M, Niculescu R, Deleanu D, Dorobantu M, Weissman NJ, Waksman R. Clinical and angiographic experience with a third-generation drug-eluting Orsiro stent in the treatment of single de novo coronary artery lesions (BIOFLOW-I): a prospective, first-in-man study. EuroIntervention. 2013 Jan 22;8(9):1006-11. doi: 10.4244/EIJV8I9A155.
PubMed 23339805
Prati F, Regar E, Mintz GS, Arbustini E, Di Mario C, Jang IK, Akasaka T, Costa M, Guagliumi G, Grube E, Ozaki Y, Pinto F, Serruys PW; Expert's OCT Review Document. Expert review document on methodology, terminology, and clinical applications of optical coherence tomography: physical principles, methodology of image acquisition, and clinical application for assessment of coronary arteries and atherosclerosis. Eur Heart J. 2010 Feb;31(4):401-15. doi: 10.1093/eurheartj/ehp433. Epub 2009 Nov 4.
PubMed 19892716
Kawamori H, Shite J, Shinke T, Otake H, Matsumoto D, Nakagawa M, Nagoshi R, Kozuki A, Hariki H, Inoue T, Osue T, Taniguchi Y, Nishio R, Hiranuma N, Hirata K. Natural consequence of post-intervention stent malapposition, thrombus, tissue prolapse, and dissection assessed by optical coherence tomography at mid-term follow-up. Eur Heart J Cardiovasc Imaging. 2013 Sep;14(9):865-75. doi: 10.1093/ehjci/jes299. Epub 2013 Jan 4.
PubMed 23291393
Mankerious N, Richardt G, Allali A, Geist V, Kastrati A, El-Mawardy M, Rheude T, Sulimov D, Toelg R, Abdel-Wahab M. Lower revascularization rates after high-speed rotational atherectomy compared to modified balloons in calcified coronary lesions: 5-year outcomes of the randomized PREPARE-CALC trial. Clin Res Cardiol. 2024 Jul;113(7):1051-1059. doi: 10.1007/s00392-024-02434-1. Epub 2024 Mar 14.
PubMed 38483633
Hemetsberger R, Gori T, Toelg R, Byrne R, Allali A, El-Mawardy M, Rheude T, Weissner M, Sulimov DS, Robinson DR, Richardt G, Abdel-Wahab M. Optical Coherence Tomography Assessment in Patients Treated With Rotational Atherectomy Versus Modified Balloons: PREPARE-CALC OCT. Circ Cardiovasc Interv. 2021 Mar;14(3):e009819. doi: 10.1161/CIRCINTERVENTIONS.120.009819. Epub 2021 Mar 1.
PubMed 33641372
Abdel-Wahab M, Toelg R, Byrne RA, Geist V, El-Mawardy M, Allali A, Rheude T, Robinson DR, Abdelghani M, Sulimov DS, Kastrati A, Richardt G. High-Speed Rotational Atherectomy Versus Modified Balloons Prior to Drug-Eluting Stent Implantation in Severely Calcified Coronary Lesions. Circ Cardiovasc Interv. 2018 Oct;11(10):e007415. doi: 10.1161/CIRCINTERVENTIONS.118.007415.
PubMed 30354632

Study at a glance

From the registry record, last updated by the sponsor on 1 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: The Comparison of Strategies to PREPARE Severely CALCified Coronary Lesions Trial (PREPARE-CALC): A Prospective Randomized Controlled Trial of Rotational Atherectomy Versus Cutting/Scoring Balloon in Severely Calcified Coronary Lesions
ClinicalTrials.gov ID: NCT02502851
Acronym / sponsor ID: PREPARE-CALC / SK 108 -- 120/14
Conditions: Coronary Atherosclerosis Due to Severely Calcified Coronary Lesion
Study type: Interventional
Recruitment status: Completed
Enrolment: 200 participants (actual)
Lead sponsor: Segeberger Kliniken GmbHUniversity, hospital or other
Study start: Sep 2014
Primary completion: Jul 2018 (actual)
Study completion: Oct 2019 (actual)
First posted: 20 Jul 2015 (estimated)
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.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Rotational Atherectomy	Active comparator	Device: Rotational AtherectomyCalcified lesion preparation using rotational atherectomy followed by implantation of the ORSIRO sirolimus-eluting stent
Cutting/Scoring Balloon	Active comparator	Device: Cutting/Scoring BalloonCalcified lesion preparation using cutting/scoring balloon followed by implantation of the ORSIRO sirolimus-eluting stent

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (10 listed)

Clinical inclusion criteria
Angiographic inclusion criteria

Key exclusion criteria (8 listed)

Clinical exclusion criteria
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 AtherectomyCalcified lesion preparation using rotational atherectomy before implantation of the Orsiro drug eluting stent	Device	Rotational Atherectomy
Cutting/Scoring BalloonCalcified lesion preparation using cutting/scoring balloons before implantation of the Orsiro drug eluting stent	Device	Cutting/Scoring Balloon

Primary outcome

Strategy Success
Time frame: Intraprocedural
The primary endpoint will be '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 crossover or stent failure
In-Stent late lumen loss at 9 months
Time frame: 9 months
Co-primary Endpoint: The in-stent late lumen loss at 9 months, defined as the difference between the postprocedure in-stent minimal lumen diameter (MLD) and the in-stent MLD at 9-month followup angiography.

7 secondary outcomes

Target vessel failure (TVF)
Time frame: 9 months, 1 year, 2 years
In-segment late lumen loss at 9 months
Time frame: 9 months
In-segment binary restenosis at 9 months
Time frame: 9 months
Stent thrombosis at 9 months, 1 and 2 years
Time frame: 9 months, 1 and 2 years
Peri-procedural MI
Time frame: within 72 hrs
Procedural duration
Time frame: Intraproedural
Amount of contrast dye
Time frame: Intraprocedural

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 Apr 2020.
Background: PubMed 18206630Kawaguchi R, Tsurugaya H, Hoshizaki H, Toyama T, Oshima S, Taniguchi K. Impact of lesion calcification on clinical and angiographic outcome after sirolimus-eluting stent implantation in real-world patients. Cardiovasc Revasc Med. 2008 Jan-Mar;9(1):2-8. doi: 10.1016/j.carrev.2007.07.004.
Background: PubMed 21596335Kuriyama N, Kobayashi Y, Yamaguchi M, Shibata Y. Usefulness of rotational atherectomy in preventing polymer damage of everolimus-eluting stent in calcified coronary artery. JACC Cardiovasc Interv. 2011 May;4(5):588-9. doi: 10.1016/j.jcin.2010.11.017. No abstract available.
Background: PubMed 24530667Madhavan MV, Tarigopula M, Mintz GS, Maehara A, Stone GW, Genereux P. Coronary artery calcification: pathogenesis and prognostic implications. J Am Coll Cardiol. 2014 May 6;63(17):1703-14. doi: 10.1016/j.jacc.2014.01.017. Epub 2014 Feb 12.
Background: PubMed 23266232Abdel-Wahab M, Richardt G, Joachim Buttner H, Toelg R, Geist V, Meinertz T, Schofer J, King L, Neumann FJ, Khattab AA. High-speed rotational atherectomy before paclitaxel-eluting stent implantation in complex calcified coronary lesions: the randomized ROTAXUS (Rotational Atherectomy Prior to Taxus Stent Treatment for Complex Native Coronary Artery Disease) trial. JACC Cardiovasc Interv. 2013 Jan;6(1):10-9. doi: 10.1016/j.jcin.2012.07.017. Epub 2012 Dec 19.
BackgroundMooney M, Teirstein P, Moses J, Turco M, Reisman M, Waksman R, Saucedo J, Mauri L, Lee D, Gershony G, Mehran R, Carlier S, Lansky A, Leon M. Final Results from the U.S. Multi-Center Trial of the AngioSculpt Scoring Balloon Catheter for the Treatment of Complex Coronary Artery Lesions. Am J Cardiol 2006;98:121.
Background: PubMed 18174614Fonseca A, Costa Jde R Jr, Abizaid A, Feres F, Abizaid AS, Costa R, Staico R, Mattos LA, Sousa AG, Grube E, Sousa JE. Intravascular ultrasound assessment of the novel AngioSculpt scoring balloon catheter for the treatment of complex coronary lesions. J Invasive Cardiol. 2008 Jan;20(1):21-7.
Background: PubMed 20636844Vaquerizo B, Serra A, Miranda F, Triano JL, Sierra G, Delgado G, Puentes A, Mojal S, Brugera J. Aggressive plaque modification with rotational atherectomy and/or cutting balloon before drug-eluting stent implantation for the treatment of calcified coronary lesions. J Interv Cardiol. 2010 Jun;23(3):240-8. doi: 10.1111/j.1540-8183.2010.00547.x.
Background: PubMed 23339805Hamon M, Niculescu R, Deleanu D, Dorobantu M, Weissman NJ, Waksman R. Clinical and angiographic experience with a third-generation drug-eluting Orsiro stent in the treatment of single de novo coronary artery lesions (BIOFLOW-I): a prospective, first-in-man study. EuroIntervention. 2013 Jan 22;8(9):1006-11. doi: 10.4244/EIJV8I9A155.
Background: PubMed 19892716Prati F, Regar E, Mintz GS, Arbustini E, Di Mario C, Jang IK, Akasaka T, Costa M, Guagliumi G, Grube E, Ozaki Y, Pinto F, Serruys PW; Expert's OCT Review Document. Expert review document on methodology, terminology, and clinical applications of optical coherence tomography: physical principles, methodology of image acquisition, and clinical application for assessment of coronary arteries and atherosclerosis. Eur Heart J. 2010 Feb;31(4):401-15. doi: 10.1093/eurheartj/ehp433. Epub 2009 Nov 4.
Background: PubMed 23291393Kawamori H, Shite J, Shinke T, Otake H, Matsumoto D, Nakagawa M, Nagoshi R, Kozuki A, Hariki H, Inoue T, Osue T, Taniguchi Y, Nishio R, Hiranuma N, Hirata K. Natural consequence of post-intervention stent malapposition, thrombus, tissue prolapse, and dissection assessed by optical coherence tomography at mid-term follow-up. Eur Heart J Cardiovasc Imaging. 2013 Sep;14(9):865-75. doi: 10.1093/ehjci/jes299. Epub 2013 Jan 4.
Derived from this study: PubMed 38483633Mankerious N, Richardt G, Allali A, Geist V, Kastrati A, El-Mawardy M, Rheude T, Sulimov D, Toelg R, Abdel-Wahab M. Lower revascularization rates after high-speed rotational atherectomy compared to modified balloons in calcified coronary lesions: 5-year outcomes of the randomized PREPARE-CALC trial. Clin Res Cardiol. 2024 Jul;113(7):1051-1059. doi: 10.1007/s00392-024-02434-1. Epub 2024 Mar 14.
Derived from this study: PubMed 33641372Hemetsberger R, Gori T, Toelg R, Byrne R, Allali A, El-Mawardy M, Rheude T, Weissner M, Sulimov DS, Robinson DR, Richardt G, Abdel-Wahab M. Optical Coherence Tomography Assessment in Patients Treated With Rotational Atherectomy Versus Modified Balloons: PREPARE-CALC OCT. Circ Cardiovasc Interv. 2021 Mar;14(3):e009819. doi: 10.1161/CIRCINTERVENTIONS.120.009819. Epub 2021 Mar 1.

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.

Mohamed Abdel-Wahab, MD principal investigator

Segeberger Kliniken GmbH

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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: finished, as of the sponsor's last update on 1 Apr 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?

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?

Strategy Success (time frame: Intraprocedural). 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?

On the ClinicalTrials.gov record for NCT02502851, which also lists 13 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 Apr 2020.