Culotte Versus DK-CRUSH Technique in Non-left Main Coronary Bifurcation Lesions

Last updated: August 4, 2022
Sponsor: University Heart Center Freiburg - Bad Krozingen
Overall Status: Active - Recruiting

Phase

N/A

Condition

Coronary Artery Disease

Treatment

N/A

Clinical Study ID

NCT04192760
UHZ Bad Krozingen-cathlab
  • Ages > 18
  • All Genders

Study Summary

Randomised comparison of Culotte technique versus "Double Kissing" - Crush technique (DK-Crush) for the percutaneous treatment of de novo non-left main coronary bifurcation lesions with modern everolimus-eluting stents (DES) - German multicenter study

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Clinical indication, evidenced by angina / angina-equivalent symptoms or documentedischemia (non-invasive imaging such as scintigraphy, stress-MRI or stress-echo; FFR oriwFR) or patients with acute coronary syndromes (NSTE-ACS).
  2. Clinical indication to perform double stenting only with Synergy™ stents for aclinically significant bifurcation stenosis as judged by the operator.
  3. De-novo non-Ieft main coronary bifurcation lesions - 1,1,1 or 0,1,1 according to theMedina classification - of a native coronary artery with the following referencevessel diameters: main branch > 2,5 mm; side branch > 2,25 mm. The difference betweenvessel diameter of the main and side branch is ≤ 1 mm.
  4. The target lesion has not been previously treated with any interventional procedure.
  5. The target vessel (main branch and side branch) must appear feasible for stentimplantation.
  6. Patient has no other coronary intervention planned within 30 days of the procedure.
  7. Patient has been informed of the nature of the study and agrees to its provisions andhas written informed consent as approved by the Ethics Committee.
  8. Patient is willing to comply with all required post-procedure follow-up.

Exclusion

Exclusion Criteria:

  1. Patient had an acute ST-elevation myocardial infarction within 72 h preceding theindex procedure or target vessel contains intraluminal thrombus.
  2. Use of any other coronary stent than Synergy™ and Synergy Megatron™ except forbaiI-out situations.
  3. Patient with a known hypersensitivity or contraindication to the needed antithrombotictherapy, stent type or contrast media that cannot be adequately pre-medicated.
  4. Non successful treatment of other lesion during the same procedure.
  5. Patient with a severe bleeding diathesis, history of recent major bleeding or stroke (≤ 6 months), coagulopathy or severe liver disease.
  6. Patient has a co-morbidity (i.e. cancer) that may cause the patient to be noncompliantwith the protocol, or is associated with limited life-expectancy (Iess than 1 year).
  7. Patient is participating in any other clinical study with an investigational product.
  8. Patient is known to be pregnant or lactating at time of inclusion.

Study Design

Total Participants: 400
Study Start date:
December 01, 2019
Estimated Completion Date:
December 31, 2023

Study Description

Aim of study This prospective randomized multicenter study will compare the long-term safety and efficacy of Culotte stenting versus "Double Kissing" - Crush (DK-Crush) stenting in the treatment of the de-novo non-left main coronary bifurcation lesions with new generation everolimus-eluting stents.

Study hypothesis In large coronary bifurcation lesions (main vessel > 2.5mm, side branch > 2.25mm) including significant ostial side branch disease, Culotte stenting compared with DKcrush stenting reduces maximal percent diameter stenosis at the bifurcation at 9-month follow-up by 25 %.

Study design Prospective, randomized, German multicenter study.

Methods Four-hundred patients, in whom a double-stenting technique is intended for the treatment of a non-left main de-novo coronary bifurcation lesion will be randomly assigned to Culotte stenting or to DK-crush stenting with an approved drug-eluting stent (SYNERGY-Stent). As a part of usual care, patients will undergo 9-month angiographic follow-up with quantitative coronary angiography. Clinical follow-up is planned at 1 year if no angiographic follow-up is obtained.

Connect with a study center

  • University Heart Center Freiburg • Bad Krozingen

    Bad Krozingen, Suedring 15 79189
    Germany

    Active - Recruiting

  • Herz-u. Diabeteszentrum

    Bad Oeynhausen, 32545
    Germany

    Active - Recruiting

  • Herz-und Gefäßzentrum

    Bad Segeberg, 23795
    Germany

    Active - Recruiting

  • St. Johannes-Hospital

    Dortmund, 44137
    Germany

    Active - Recruiting

  • Herzzentrum Dresden an der Technischen Universität

    Dresden, 01307
    Germany

    Active - Recruiting

  • Elisabeth Krankenhaus

    Essen, 45138
    Germany

    Active - Recruiting

  • Universitätsklinikum Freiburg/UHZ

    Freiburg, 79110
    Germany

    Site Not Available

  • Universitätsklinikum Gießen

    Gießen, 35392
    Germany

    Active - Recruiting

  • Universitätsklinikum Leipzig

    Leipzig, 04103
    Germany

    Active - Recruiting

  • Universitätsklinik Mannheim

    Mannheim, 68167
    Germany

    Active - Recruiting

  • Deutsches Herzzentrum

    München, 80636
    Germany

    Active - Recruiting

  • Klinikum Oldenburg

    Oldenburg, 26133
    Germany

    Active - Recruiting

  • Herzzentrum Trier

    Trier, 54292
    Germany

    Active - Recruiting

  • Universitätsklinikum Ulm

    Ulm, 89070
    Germany

    Active - Recruiting

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