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

NCT02502851 | Completed DMC

• 1 other identifier: SK 108 -- 120/14
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Coronary Atherosclerosis Due to Severely Calcified Coronary Lesion

Outcome Measures

Primary Outcomes (2)

• 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

  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.

  9 months

Secondary Outcomes (7)

• Target vessel failure (TVF)

  9 months, 1 year, 2 years

• In-segment late lumen loss at 9 months

  9 months

• In-segment binary restenosis at 9 months

  9 months

• Stent thrombosis at 9 months, 1 and 2 years

  9 months, 1 and 2 years

• Peri-procedural MI

  within 72 hrs

Study Arms (2)

Rotational Atherectomy

ACTIVE COMPARATOR

Calcified lesion preparation using rotational atherectomy followed by implantation of the ORSIRO sirolimus-eluting stent

Device: Rotational Atherectomy

Cutting/Scoring Balloon

ACTIVE COMPARATOR

Calcified lesion preparation using cutting/scoring balloon followed by implantation of the ORSIRO sirolimus-eluting stent

Device: Cutting/Scoring Balloon

Interventions

Rotational Atherectomy DEVICE

Calcified lesion preparation using rotational atherectomy before implantation of the Orsiro drug eluting stent

Rotational Atherectomy

Cutting/Scoring Balloon DEVICE

Calcified lesion preparation using cutting/scoring balloons before implantation of the Orsiro drug eluting stent

Cutting/Scoring Balloon

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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

You may not qualify if:

• Myocardial infarction (within 1 week)
• Decompensated heart failure
• Limited long term prognosis due to other conditions
• Target lesion is in a coronary artery bypass graft
• Target lesion is an in-stent restenosis
• Target vessel thrombus

Sponsors & Collaborators

• Segeberger Kliniken GmbH: lead

Study Sites (1)

Segeberger Kliniken GmbH

Bad Segeberg, Schleswig-Holstein, 23795, Germany

Location

Related Publications (13)

• 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.

  PMID: 18206630 BACKGROUND

• 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.

  PMID: 21596335 BACKGROUND

• 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.

  PMID: 24530667 BACKGROUND

• 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.

  PMID: 23266232 BACKGROUND

• 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.

  BACKGROUND

• 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.

  PMID: 18174614 BACKGROUND

• 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.

  PMID: 20636844 BACKGROUND

• 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.

  PMID: 23339805 BACKGROUND

• 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.

  PMID: 19892716 BACKGROUND

• 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.

  PMID: 23291393 BACKGROUND

• 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.

  PMID: 38483633 DERIVED

• 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.

  PMID: 33641372 DERIVED

• 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.

  PMID: 30354632 DERIVED

MeSH Terms

Interventions

Atherectomy, Coronary

Intervention Hierarchy (Ancestors)

Atherectomy; Angioplasty; Catheterization; Therapeutics; Myocardial Revascularization; Cardiac Surgical Procedures; Cardiovascular Surgical Procedures; Surgical Procedures, Operative; Endovascular Procedures; Vascular Surgical Procedures; Percutaneous Coronary Intervention; Minimally Invasive Surgical Procedures; Thoracic Surgical Procedures; Investigative Techniques

Study Officials

• Mohamed Abdel-Wahab, MD

  Segeberger Kliniken GmbH

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 13, 2015
• First Posted: July 20, 2015
• Study Start: September 1, 2014
• Primary Completion: July 1, 2018
• Study Completion: October 1, 2019
• Last Updated: April 1, 2020

Record last verified: 2020-03

Locations

DE (1)