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Trial record 1 of 1 for:    BBK-3
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Culotte Versus DK-CRUSH Technique in Non-left Main Coronary Bifurcation Lesions (BBK-3)

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ClinicalTrials.gov Identifier: NCT04192760
Recruitment Status : Recruiting
First Posted : December 10, 2019
Last Update Posted : December 20, 2019
Sponsor:
Information provided by (Responsible Party):
Dr. Miroslaw FERENC, University Heart Center Freiburg - Bad Krozingen

Brief 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) - European multicenter study

Condition or disease Intervention/treatment Phase
Coronary Stenosis Stent Stenosis Procedure: Stenting Not Applicable

Detailed 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 %, relative.

Study design Prospective, randomized, European 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 30 days, 6 months, 1 year and 2 years.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 400 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Bifurcations Bad Krozingen (BBK) 3 - Trial Randomised Comparison of Culotte-stenting Versus DK-Crush--stenting for the Treatment of de Novo Non-left Main Coronary Bifurcation Lesions With Everolimus-eluting Stents
Estimated Study Start Date : December 2019
Estimated Primary Completion Date : December 2021
Estimated Study Completion Date : December 2021

Arm Intervention/treatment
Active Comparator: Culotte Technique

Both vessels have to be wired. Lesion preparation in the main vessel and side branch may be undertaken according to operator preference. After lesion preparation, the side branch has to be stented first.

The first stent is placed from main branch into the side branch side branch, covering the entire diseased segment with a wire jailed in the main vessel. The main vessel is rewired through the stent struts, and after removal of the jailed wire, is dilated with a balloon to separate stent struts. The side branch wire is then removed (to prevent metal-to-metal jail) and the main vessel is stented covering the proximal and distal segment. The side-branch is re-wired and high pressure (e.g. 20 atm) individual inflations are made in each vessel at the bifurcation point to ensure good stent strut separation. Finally, a lower pressure kissing inflation is made.

Procedure: Stenting
Comparison of two technical approaches in the interventional treatment on de-novo non-left main coronary lesions

Active Comparator: DK-Crush Technique
Both vessels have to be wired first. Lesion preparation in the main vessel and side branch may be undertaken according to operator preference (rotablation, if needed). After lesion preparation, the side branch is stented first. Side branch stent should have a small protrusion into the main branch. Before stent implantation in the side branch, an adequately sized balloon should be placed in the main branch, just opposite to the side branch ostium. After stent implantation in the side branch, stent balloon and wire are removed and the balloon in the main branch must be inflated, to crush the struts into the vessel wall. In next step, the new wire should be crossed into the ostium of the side branch and first kissing balloon dilatation will follow. The next step is to implant the second stent into the main branch, followed by a second kissing balloon-dilatation and final proximal optimisation (POT) procedure (single balloon inflation in proximal segment).
Procedure: Stenting
Comparison of two technical approaches in the interventional treatment on de-novo non-left main coronary lesions




Primary Outcome Measures :
  1. Angiographic restenosis in the bifurcation lesion by quantitative coronary analysis (QCA) [ Time Frame: 9 months post index percutaneous coronary intervention (PCI) ]

    For quantitative coronary angiography, changes between result at the completion of the index intervention and at 9 months follow-up will be analysed using a computer based system dedicated to bifurcation analysis, according to the standard operating procedure of the angiographic core laboratory.

    Quantitative angiographic measurements will be obtained of the three segments of the bifurcation lesion: the proximal and distal segment of the main branch and the side branch. We will perform measurements in the stented portion of the vessel (in-stent) and in the distal or proximal 5 mm margin (edge). In-segment analyses will comprise the in-stent and the edge area.

    In addition, the bifurcation angle from the analysis system will be estimated.



Secondary Outcome Measures :
  1. Incidence of target lesion revascularisation (TLR) [ Time Frame: 30 days, 6 months, 1 year, 2 years ]
    Any revascularisation (Re-PCI or CABG) at segments treated during index procedure

  2. Incidence of major adverse cardiac events (MACE) [ Time Frame: 30 days, 6 months, 1 year, 2 years ]
    MACE defined as death, Myocardial infarction (Q wave and Non-Q wave), emergent cardiac bypass surgery, or TLR

  3. Incidence of binary restenosis at any segment of the bifurcation [ Time Frame: 9 months ]
    ≥ 50% diameter stenosis in the main and side branch

  4. Incidence of binary restenosis in the main and side branch [ Time Frame: 9 months ]
    ≥ 50% diameter stenosis in main and side branch

  5. Incidence of stent thrombosis (ST) [ Time Frame: 1 year, 2 year ]
    Post-procedure thrombotic stent occlusion according to the Academic Research Consortium-criteria


Other Outcome Measures:
  1. Rate of device success [ Time Frame: 9 months ]
    Attainment of < 30% residual stenosis of the target lesion in the main and side branch

  2. Mean procedure time [ Time Frame: Index Intervention ]
    Procedure time measured in minutes

  3. Mean radiation exposure [ Time Frame: Index Intervention ]
    Radiation exposure measured in mGym²

  4. Mean volume of used contrast medium [ Time Frame: Index Intervention ]
    Contrast medium measured in milliliters



Information from the National Library of Medicine

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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 indication (symptoms, ischemia documented or patients with acute coronary syndromes (NSTEMI) for interventional treatment of the bifurcation lesion.

2. Clinical indication to perform the double stenting as judged by the operator.

3. De-novo non-left main coronary bifurcation lesions according to the Medina classification of a native coronary artery with a reference vessel diameter: main branch >2,5 mm; side branch >2,25 mm (the difference between vessel diameter of the main and side branch should be ≤1 mm)

  • Target lesion (main branch and / or side branch) with at least 50% diameter stenosis or fractional flow reserve (FFR) < 0.80.
  • The target lesion has not been previously treated with any interventional procedure.
  • The target vessel (main branch and side branch) must be feasible for stent implantation (successful passage with the guide wire; successful pre-dilatation with an appropriately sized balloon; lesion preparation, if needed
  • Patient has no other treatment planned within 30 days of the procedure.
  • Patient has been informed of the nature of the study and agrees to its provisions and has written informed consent as approved by the Ethics Committee.
  • Patient is willing to comply all required post-procedure follow-up.

Exclusion Criteria:

  • 1. Patient had an acute myocardial infarction (> 3x normal creatine kinase (CK)) within 72 hours preceding the index procedure and CK has not returned to normal limits at the time of the procedure.

    2. Patient with a known hypersensitivity or contraindication to aspirin, heparin, clopidogrel, prasugrel, ticagrelor, stainless steel, everolimus or contrast media that cannot be adequately pre-medicated.

    3. Non successful treatment of other lesion during the same procedure

    4. Patient with a platelet count of <100,000 cells/mm³ or >700,000 cells/mm³, white blood cells of <3,000 cells/mm³, or documented or liver disease.

    5. Patient with a history of bleeding diathesis or coagulopathy.

    6. Patient has suffered a stroke within the past six months.

    7. Active peptic ulcer or upper gastrointestinal bleeding within the prior 6 months.

    8. Patient has a co-morbidity (i.e. cancer or congestive heart failure) that may cause the patient to be non-compliant with the protocol, or is associated with limited life-expectancy (less than 2 years).

    9. Patient must be excluded from the study if any of these angiographic criteria are met:

    1. The target vessel contains intraluminal thrombus.
    2. The patient has undergone previous PCI to the target vessel within 6 months.

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): NCT04192760


Locations
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Germany
University Heart Center Freiburg • Bad Krozingen Recruiting
Bad Krozingen, Suedring 15, Germany, 79189
Contact: Miroslaw Ferenc, Dr.    0049 7633 4020    Miroslaw.Ferenc@universitaets-herzzentrum.de   
Contact: Franz-Josef Neumann, Prof. Dr.    0049 7633 4020    Franz-Josef.Neumann@universitaets-herzzentrum.de   
Principal Investigator: Miroslaw Ferenc, MD         
Sponsors and Collaborators
University Heart Center Freiburg - Bad Krozingen
  Study Documents (Full-Text)

Documents provided by Dr. Miroslaw FERENC, University Heart Center Freiburg - Bad Krozingen:
Study Protocol  [PDF] July 20, 2019
Statistical Analysis Plan  [PDF] December 9, 2019

Publications of Results:

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Responsible Party: Dr. Miroslaw FERENC, Director of interventional cardiology department, University Heart Center Freiburg - Bad Krozingen
ClinicalTrials.gov Identifier: NCT04192760    
Other Study ID Numbers: UHZ Bad Krozingen-cathlab
First Posted: December 10, 2019    Key Record Dates
Last Update Posted: December 20, 2019
Last Verified: December 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Dr. Miroslaw FERENC, University Heart Center Freiburg - Bad Krozingen:
PCI
stent
bifurcation
Culotte
DK-Crush
restenosis
Additional relevant MeSH terms:
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Coronary Stenosis
Constriction, Pathologic
Pathological Conditions, Anatomical
Coronary Disease
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases