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

Primary Purpose

Coronary Atherosclerosis Due to Severely Calcified Coronary Lesion

Status
Completed
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
Rotational Atherectomy
Cutting/Scoring Balloon
Sponsored by
Segeberger Kliniken GmbH
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Coronary Atherosclerosis Due to Severely Calcified Coronary Lesion

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Segeberger Kliniken GmbH

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Rotational Atherectomy

Cutting/Scoring Balloon

Arm Description

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

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

Outcomes

Primary Outcome Measures

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
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.

Secondary Outcome Measures

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
In-segment late lumen loss at 9 months
In-segment late lumen loss (stent length + 5 mm on either side) at 9 months
In-segment binary restenosis at 9 months
In-segment binary restenosis (diameter stenosis ≥ 50%) at 9 months
Stent thrombosis at 9 months, 1 and 2 years
Stent thrombosis at 9 months, 1 and 2 years
Peri-procedural MI
Procedural duration
Amount of contrast dye

Full Information

First Posted
July 13, 2015
Last Updated
March 31, 2020
Sponsor
Segeberger Kliniken GmbH
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1. Study Identification

Unique Protocol Identification Number
NCT02502851
Brief Title
The Comparison of Strategies to PREPARE Severely CALCified Coronary Lesions Trial (PREPARE-CALC)
Acronym
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

2. Study Status

Record Verification Date
March 2020
Overall Recruitment Status
Completed
Study Start Date
September 2014 (undefined)
Primary Completion Date
July 2018 (Actual)
Study Completion Date
October 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Segeberger Kliniken GmbH

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary Atherosclerosis Due to Severely Calcified Coronary Lesion

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
200 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Rotational Atherectomy
Arm Type
Active Comparator
Arm Description
Calcified lesion preparation using rotational atherectomy followed by implantation of the ORSIRO sirolimus-eluting stent
Arm Title
Cutting/Scoring Balloon
Arm Type
Active Comparator
Arm Description
Calcified lesion preparation using cutting/scoring balloon followed by implantation of the ORSIRO sirolimus-eluting stent
Intervention Type
Device
Intervention Name(s)
Rotational Atherectomy
Intervention Description
Calcified lesion preparation using rotational atherectomy before implantation of the Orsiro drug eluting stent
Intervention Type
Device
Intervention Name(s)
Cutting/Scoring Balloon
Intervention Description
Calcified lesion preparation using cutting/scoring balloons before implantation of the Orsiro drug eluting stent
Primary Outcome Measure Information:
Title
Strategy Success
Description
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
Time Frame
Intraprocedural
Title
In-Stent late lumen loss at 9 months
Description
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.
Time Frame
9 months
Secondary Outcome Measure Information:
Title
Target vessel failure (TVF)
Description
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
Time Frame
9 months, 1 year, 2 years
Title
In-segment late lumen loss at 9 months
Description
In-segment late lumen loss (stent length + 5 mm on either side) at 9 months
Time Frame
9 months
Title
In-segment binary restenosis at 9 months
Description
In-segment binary restenosis (diameter stenosis ≥ 50%) at 9 months
Time Frame
9 months
Title
Stent thrombosis at 9 months, 1 and 2 years
Description
Stent thrombosis at 9 months, 1 and 2 years
Time Frame
9 months, 1 and 2 years
Title
Peri-procedural MI
Time Frame
within 72 hrs
Title
Procedural duration
Time Frame
Intraproedural
Title
Amount of contrast dye
Time Frame
Intraprocedural

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 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: 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mohamed Abdel-Wahab, MD
Organizational Affiliation
Segeberger Kliniken GmbH
Official's Role
Principal Investigator
Facility Information:
Facility Name
Segeberger Kliniken GmbH
City
Bad Segeberg
State/Province
Schleswig-Holstein
ZIP/Postal Code
23795
Country
Germany

12. IPD Sharing Statement

Citations:
PubMed Identifier
18206630
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.
Results Reference
background
PubMed Identifier
21596335
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.
Results Reference
background
PubMed Identifier
24530667
Citation
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.
Results Reference
background
PubMed Identifier
23266232
Citation
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.
Results Reference
background
Citation
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.
Results Reference
background
PubMed Identifier
18174614
Citation
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.
Results Reference
background
PubMed Identifier
20636844
Citation
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.
Results Reference
background
PubMed Identifier
23339805
Citation
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.
Results Reference
background
PubMed Identifier
19892716
Citation
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.
Results Reference
background
PubMed Identifier
23291393
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.
Results Reference
background
PubMed Identifier
33641372
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.
Results Reference
derived
PubMed Identifier
30354632
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. Erratum In: Circ Cardiovasc Interv. 2018 Oct;11(10):e000040.
Results Reference
derived

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

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