Clinical trial NCT02502851: The Comparison of Strategies to PREPARE Severely CALCified Coronary Lesions Trial (PREPARE-CALC)
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Coronary Atherosclerosis Due to Severely Calcified Coronary Lesion
Lead sponsor: Segeberger Kliniken GmbH
Sponsor class: OTHER
First posted: 2015-07-20
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: Inclusion Criteria:

1. 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
2. Angiographic inclusion criteria

   * 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

Exclusion Criteria:

1. Clinical exclusion criteria

   * Myocardial infarction (within 1 week)
   * Decompensated heart failure
   * Limited long term prognosis due to other conditions
2. Angiographic exclusion criteria

   * Target lesion is in a coronary artery bypass graft
   * Target lesion is an in-stent restenosis
   * Target vessel thrombus

Primary outcomes:
measure: Strategy Success
timeFrame: Intraprocedural
measure: In-Stent late lumen loss at 9 months
timeFrame: 9 months
Secondary outcomes:
measure: Target vessel failure (TVF)
timeFrame: 9 months, 1 year, 2 years
measure: In-segment late lumen loss at 9 months
timeFrame: 9 months
measure: In-segment binary restenosis at 9 months
timeFrame: 9 months
measure: Stent thrombosis at 9 months, 1 and 2 years
timeFrame: 9 months, 1 and 2 years
measure: Peri-procedural MI
timeFrame: within 72 hrs
measure: Procedural duration
timeFrame: Intraproedural
measure: Amount of contrast dye
timeFrame: Intraprocedural
Other outcomes:
Locations:
city: Bad Segeberg
country: Germany
facility: Segeberger Kliniken GmbH
state: Schleswig-Holstein
Study officials:
affiliation: Segeberger Kliniken GmbH
name: Mohamed Abdel-Wahab, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
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citation: 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.
citation: 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.
citation: 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.