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

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ClinicalTrials.gov Identifier: NCT02502851
Recruitment Status : Active, not recruiting
First Posted : July 20, 2015
Last Update Posted : March 9, 2018
Sponsor:
Information provided by (Responsible Party):
Herz-Kreislauf-Zentrum Segeberger Kliniken GmbH

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.

Condition or disease Intervention/treatment Phase
Coronary Atherosclerosis Due to Severely Calcified Coronary Lesion Device: Rotational Atherectomy Device: Cutting/Scoring Balloon Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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 Start Date : September 2014
Estimated Primary Completion Date : August 2018
Estimated Study Completion Date : December 2020

Arm Intervention/treatment
Active Comparator: Rotational Atherectomy
Calcified lesion preparation using rotational atherectomy followed by implantation of the ORSIRO sirolimus-eluting stent
Device: Rotational Atherectomy
Calcified lesion preparation using rotational atherectomy before implantation of the Orsiro drug eluting stent

Active Comparator: Cutting/Scoring Balloon
Calcified lesion preparation using cutting/scoring balloon followed by implantation of the ORSIRO sirolimus-eluting stent
Device: Cutting/Scoring Balloon
Calcified lesion preparation using cutting/scoring balloons before implantation of the Orsiro drug eluting stent




Primary Outcome Measures :
  1. 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

  2. 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.


Secondary Outcome Measures :
  1. Target vessel failure (TVF) [ Time Frame: 9 months, 1 year, 2 years ]
    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

  2. In-segment late lumen loss at 9 months [ Time Frame: 9 months ]
    In-segment late lumen loss (stent length + 5 mm on either side) at 9 months

  3. In-segment binary restenosis at 9 months [ Time Frame: 9 months ]
    In-segment binary restenosis (diameter stenosis ≥ 50%) at 9 months

  4. Stent thrombosis at 9 months, 1 and 2 years [ Time Frame: 9 months, 1 and 2 years ]
    Stent thrombosis at 9 months, 1 and 2 years

  5. Peri-procedural MI [ Time Frame: within 72 hrs ]
  6. Procedural duration [ Time Frame: Intraproedural ]
  7. Amount of contrast dye [ Time Frame: Intraprocedural ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02502851


Locations
Germany
Segeberger Kliniken GmbH
Bad Segeberg, Schleswig-Holstein, Germany, 23795
Sponsors and Collaborators
Herz-Kreislauf-Zentrum Segeberger Kliniken GmbH
Investigators
Principal Investigator: Mohamed Abdel-Wahab, MD Segeberger Kliniken GmbH

Publications:
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.

Responsible Party: Herz-Kreislauf-Zentrum Segeberger Kliniken GmbH
ClinicalTrials.gov Identifier: NCT02502851     History of Changes
Other Study ID Numbers: SK 108 -- 120/14
First Posted: July 20, 2015    Key Record Dates
Last Update Posted: March 9, 2018
Last Verified: March 2018

Additional relevant MeSH terms:
Atherosclerosis
Coronary Artery Disease
Myocardial Ischemia
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases
Coronary Disease
Heart Diseases