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PREPARE-CALC-COMBO: Severely Calcified Coronary Lesions Prepared With Rotational Atherectomy and Modified Balloons

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ClinicalTrials.gov Identifier: NCT04014595
Recruitment Status : Recruiting
First Posted : July 10, 2019
Last Update Posted : July 26, 2019
Sponsor:
Information provided by (Responsible Party):
Segeberger Kliniken GmbH

Brief Summary:
A prospective single-arm trial of rotational atherectomy in combination with cutting balloon in severely calcified coronary lesions.

Condition or disease Intervention/treatment
Coronary Artery Disease Procedure: Rotational atherectomy in combination with cutting balloon

Detailed Description:
A prospective single-arm trial to evaluate the acute and long term efficacy of a combined strategy of lesion preparation with rotational atherectomy followed by cutting balloon and by hybrid sirolimus-eluting stent implantation in an angiographically well-defined group of patients with severely calcified coronary lesions.

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Study Type : Observational [Patient Registry]
Estimated Enrollment : 100 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 2 Years
Official Title: The Evaluation of a Strategy to PREPARE Severely CALCified Coronary Lesions With a Combination Of Rotational Atherectomy and Modified BallOons Trial (PREPARE-CALC- COMBO)
Actual Study Start Date : January 1, 2019
Estimated Primary Completion Date : January 31, 2020
Estimated Study Completion Date : January 31, 2022

Group/Cohort Intervention/treatment
Rotational atherectomy + Cutting Balloon
Rotational atherectomy in combination with cutting balloon in severely calcified coronary lesions
Procedure: Rotational atherectomy in combination with cutting balloon
Treatment of severely calcified coronary lesion using rotational atherectomy followed by balloon angioplasty using a cutting balloon and Implantation of the hybrid sirolimus-eluting stent.




Primary Outcome Measures :
  1. Primary endpoint: Numerical in-stent acute lumen gain in mm [ Time Frame: At the end of the index procedure ]
    The main angiographic endpoint will be in-stent acute lumen gain defined as minimal lumen diameter (MLD) in stent at the end of the index procedure minus baseline MLD.

  2. Co-primary OCT endpoint: Ratio of stent expansion index (SEI) [ Time Frame: At the end of the index procedure ]
    The main OCT endpoint will be stent expansion index (SEI), defined as minimum stent area divided by mean reference area in optical coherence tomography (OCT) quantitative analysis at the end of the index procedure


Secondary Outcome Measures :
  1. Numerical in-stent late lumen loss at 9 month follow-up angiography in mm [ Time Frame: 9 months follow-up ]
    In-stent late lumen loss at 9 month follow-up angiography defined as the difference between the postprocedure in-stent minimal lumen diameter (MLD)and the in-stent MLD at 9-month followup angiography will be adopted as a co-primary endpoint.

  2. Rate of angiographic success in percent [ Time Frame: Peri-procedural ]
    'Angiographic 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.

  3. Rate of strategy success in percent [ Time Frame: Peri-procedural ]
    '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 stent failure.

  4. Rate of target vessel failure in percent [ Time Frame: 9 months, 1 and 2 years follow-up ]
    Target vessel failure (TVF) defined as a composite of cardiac death, target vessel related myocardial infarction and clinically driven target vessel revascularization at 9 months, 1 and 2 years.

  5. Rate of in-segment binary restenosis at 9 months in percent [ Time Frame: 9 months follow-up ]
    In-segment binary restenosis at 9 months

  6. Rate of stent thrombosis in percent [ Time Frame: 9 months, 1 and 2 years follow-up ]
    Stent thrombosis

  7. Rate of peri-procedural myocardial infarction in percent [ Time Frame: Peri-procedural ]
    Peri-procedural myocardial infarction

  8. Rate of vessel perforation in percent [ Time Frame: Peri-procedural ]
    Rate of vessel perforation

  9. Numerical procedural duration in min [ Time Frame: Peri-procedural ]
    Procedural duration

  10. Numerical contrast dye amount in ml [ Time Frame: Peri-procedural ]
    Procedural contrast dye amount


Other Outcome Measures:
  1. Ratio of OCT-measured stent excentricity index [ Time Frame: Intra-procedural ]
    Defined as the ratio of minimal lumen diameter and the maximal lumen diameter per cross section at the end of index procedure



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with coronary artery disease subjected to percutaneous revascularization of the native coronary arteries and fullfilling all of the inclusion criteria and none of the exclusion criteria.
Criteria

Inclusion Criteria:

Clinical inclusion criteria

  1. Age above 18 years and consentable
  2. Angiographically proven coronary artery disease
  3. Anginal symptoms and/or reproducible ischemia in the target area by ECG, functional stress testing or fractional flow reserve
  4. Written informed consent

Angiographic inclusion criteria

  1. De-novo lesion in a native coronary artery
  2. Target reference vessel diameter between 2.25 and 4.0 mm by visual estimation
  3. Luminal diameter reduction of 50-100% by visual estimation
  4. Severe calcification of the target lesion (for definition see appendix)

Exclusion Criteria:

Clinical exclusion criteria

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

Angiographic exclusion criteria

  1. Target lesion is in a coronary artery bypass graft
  2. Target lesion is an in-stent restenosis
  3. 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): NCT04014595


Contacts
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Contact: Abdelhakim Allali, MD +494551802 ext 4801 abdelhakim.allali@segebergerkliniken.de
Contact: Ralph Tölg, P.D. , MD +494551802 ext 4801 ralph.toelg@segebergerkliniken.de

Locations
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Germany
Herzzentrum Segeberger Kliniken GmbH Recruiting
Bad Segeberg, Germany, 23795
Contact: Gert Richardt, MD    +49 4551 802 4801    gert.richardt@segebergerkliniken.de   
Sponsors and Collaborators
Segeberger Kliniken GmbH
Investigators
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Study Chair: Gert Richardt, Prof. Herzzentrum Segeberger Kliniken GmbH

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Responsible Party: Segeberger Kliniken GmbH
ClinicalTrials.gov Identifier: NCT04014595     History of Changes
Other Study ID Numbers: SK 110 -- 168/11
First Posted: July 10, 2019    Key Record Dates
Last Update Posted: July 26, 2019
Last Verified: July 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
Keywords provided by Segeberger Kliniken GmbH:
Calcified coronary lesions
Additional relevant MeSH terms:
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Coronary Artery Disease
Coronary Disease
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases