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Culotte Versus DK-CRUSH Technique in Non-left Main Coronary Bifurcation Lesions (BBK-3)

Primary Purpose

Coronary Stenosis, Stent Stenosis

Status

Recruiting

Phase

Not Applicable

Locations

Germany

Study Type

Interventional

Intervention

Stenting

About this trial

This is an interventional treatment trial for Coronary Stenosis focused on measuring PCI, stent, bifurcation, Culotte, DK-Crush, restenosis

Eligibility Criteria

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

Inclusion Criteria:

Clinical indication, evidenced by angina / angina-equivalent symptoms or documented ischemia (non-invasive imaging such as scintigraphy, stress-MRI or stress-echo; FFR or iwFR) or patients with acute coronary syndromes (NSTE-ACS).
Clinical indication to perform double stenting only with Synergy™ stents for a clinically significant bifurcation stenosis as judged by the operator.
De-novo non-Ieft main coronary bifurcation lesions - 1,1,1 or 0,1,1 according to the Medina classification - of a native coronary artery with the following reference vessel diameters: main branch > 2,5 mm; side branch > 2,25 mm. The difference between vessel diameter of the main and side branch is ≤ 1 mm.
The target lesion has not been previously treated with any interventional procedure.
The target vessel (main branch and side branch) must appear feasible for stent implantation.
Patient has no other coronary intervention 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 with all required post-procedure follow-up.

Exclusion Criteria:

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

Sites / Locations

University Heart Center Freiburg • Bad KrozingenRecruiting
Herz-u. DiabeteszentrumRecruiting
Herz-und GefäßzentrumRecruiting
St. Johannes-HospitalRecruiting
Herzzentrum Dresden an der Technischen UniversitätRecruiting
Elisabeth KrankenhausRecruiting
Universitätsklinikum GießenRecruiting
Universitätsklinikum LeipzigRecruiting
Universitätsklinik MannheimRecruiting
Deutsches HerzzentrumRecruiting
Klinikum OldenburgRecruiting
Herzzentrum TrierRecruiting
Universitätsklinikum UlmRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Arm Label

Culotte Technique

DK-Crush Technique

Arm Description

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, 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 and the main vessel is stented covering the proximal and distal segment. The side-branch is re-wired and high pressure individual inflations are made in each vessel at the bifurcation point to ensure good stent strut separation. Afterwards, a lower pressure kissing inflation is made. Balloon sizing should be in accordance with the diameter of the vessel itself. Finally, a proximal optimization (POT) procedure is performed.

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 second re-wiring, a second kissing balloon-dilatation and final proximal optimization (POT) procedure (single short balloon inflation in proximal segment).

Outcomes

Primary Outcome Measures

Angiographic restenosis in the bifurcation lesion by quantitative coronary analysis (QCA)

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

Incidence of target lesion revascularisation (TLR)

Any revascularisation (Re-PCI or CABG) at segments treated during index procedure

Incidence of major adverse cardiac events (MACE)

MACE defined as death, Myocardial infarction (Q wave and Non-Q wave), emergent cardiac bypass surgery, or TLR

Incidence of binary restenosis at any segment of the bifurcation lesion

≥ 50% diameter stenosis in the main and side branch

Incidence of binary restenosis in the main and side branch

≥ 50% diameter stenosis in main and side branch

Incidence of stent thrombosis (ST)

Post-procedure thrombotic stent occlusion according to the Academic Research Consortium-criteria

Full Information

NCT ID

NCT04192760

First Posted

November 27, 2019

Last Updated

August 4, 2022

Sponsor

University Heart Center Freiburg - Bad Krozingen

1. Study Identification

Unique Protocol Identification Number

NCT04192760

Brief Title

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

Acronym

BBK-3

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

Study Type

Interventional

2. Study Status

Record Verification Date

August 2022

Overall Recruitment Status

Recruiting

Study Start Date

December 1, 2019 (Actual)

Primary Completion Date

March 31, 2023 (Anticipated)

Study Completion Date

December 31, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

University Heart Center Freiburg - Bad Krozingen

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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) - German multicenter study

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 %. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Coronary Stenosis, Stent Stenosis

Keywords

PCI, stent, bifurcation, Culotte, DK-Crush, restenosis

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

400 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Culotte Technique

Arm Type

Active Comparator

Arm Description

Arm Title

DK-Crush Technique

Arm Type

Active Comparator

Arm Description

Intervention Type

Procedure

Intervention Name(s)

Stenting

Intervention Description

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

Primary Outcome Measure Information:

Title

Angiographic restenosis in the bifurcation lesion by quantitative coronary analysis (QCA)

Description

Time Frame

9 months post index percutaneous coronary intervention (PCI)

Secondary Outcome Measure Information:

Title

Incidence of target lesion revascularisation (TLR)

Description

Any revascularisation (Re-PCI or CABG) at segments treated during index procedure

Time Frame

1 year

Title

Incidence of major adverse cardiac events (MACE)

Description

MACE defined as death, Myocardial infarction (Q wave and Non-Q wave), emergent cardiac bypass surgery, or TLR

Time Frame

1 year

Title

Incidence of binary restenosis at any segment of the bifurcation lesion

Description

≥ 50% diameter stenosis in the main and side branch

Time Frame

9 months

Title

Incidence of binary restenosis in the main and side branch

Description

≥ 50% diameter stenosis in main and side branch

Time Frame

9 months

Title

Incidence of stent thrombosis (ST)

Description

Post-procedure thrombotic stent occlusion according to the Academic Research Consortium-criteria

Time Frame

1 year

Other Pre-specified Outcome Measures:

Title

Rate of device success

Description

Attainment of < 30% residual stenosis of the target lesion in the main and side branch

Time Frame

9 months

Title

Mean procedure time

Description

Procedure time measured in minutes

Time Frame

Index Intervention

Title

Mean radiation exposure

Description

Radiation exposure measured in cGym²

Time Frame

Index Intervention

Title

Mean volume of used contrast medium

Description

Contrast medium measured in milliliters

Time Frame

Index Intervention

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Clinical indication, evidenced by angina / angina-equivalent symptoms or documented ischemia (non-invasive imaging such as scintigraphy, stress-MRI or stress-echo; FFR or iwFR) or patients with acute coronary syndromes (NSTE-ACS). Clinical indication to perform double stenting only with Synergy™ stents for a clinically significant bifurcation stenosis as judged by the operator. De-novo non-Ieft main coronary bifurcation lesions - 1,1,1 or 0,1,1 according to the Medina classification - of a native coronary artery with the following reference vessel diameters: main branch > 2,5 mm; side branch > 2,25 mm. The difference between vessel diameter of the main and side branch is ≤ 1 mm. The target lesion has not been previously treated with any interventional procedure. The target vessel (main branch and side branch) must appear feasible for stent implantation. Patient has no other coronary intervention 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 with all required post-procedure follow-up. Exclusion Criteria: Patient had an acute ST-elevation myocardial infarction within 72 h preceding the index procedure or target vessel contains intraluminal thrombus. Use of any other coronary stent than Synergy™ and Synergy Megatron™ except for baiI-out situations. Patient with a known hypersensitivity or contraindication to the needed antithrombotic therapy, stent type or contrast media that cannot be adequately pre-medicated. Non successful treatment of other lesion during the same procedure. Patient with a severe bleeding diathesis, history of recent major bleeding or stroke (≤ 6 months), coagulopathy or severe liver disease. Patient has a co-morbidity (i.e. cancer) that may cause the patient to be noncompliant with the protocol, or is associated with limited life-expectancy (Iess than 1 year). Patient is participating in any other clinical study with an investigational product. Patient is known to be pregnant or lactating at time of inclusion.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Miroslaw Ferenc, MD

Phone

0049 7633 4020

miroslaw.ferenc@uniklinik-freiburg.de

Facility Information:

Facility Name

University Heart Center Freiburg • Bad Krozingen

City

Bad Krozingen

State/Province

Suedring 15

ZIP/Postal Code

79189

Country

Germany

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Miroslaw Ferenc, PD Dr.

Phone

0049 7633 4020

Miroslaw.Ferenc@universitaets-herzzentrum.de

First Name & Middle Initial & Last Name & Degree

Franz-Josef Neumann, Prof. Dr.

Phone

0049 7633 4020

Franz-Josef.Neumann@universitaets-herzzentrum.de

First Name & Middle Initial & Last Name & Degree

Miroslaw Ferenc, MD

Facility Name

Herz-u. Diabeteszentrum

City

Bad Oeynhausen

ZIP/Postal Code

32545

Country

Germany

Individual Site Status

Recruiting

Facility Name

Herz-und Gefäßzentrum

City

Bad Segeberg

ZIP/Postal Code

23795

Country

Germany

Individual Site Status

Recruiting

Facility Name

St. Johannes-Hospital

City

Dortmund

ZIP/Postal Code

44137

Country

Germany

Individual Site Status

Recruiting

Facility Name

Herzzentrum Dresden an der Technischen Universität

City

Dresden

ZIP/Postal Code

01307

Country

Germany

Individual Site Status

Recruiting

Facility Name

Elisabeth Krankenhaus

City

Essen

ZIP/Postal Code

45138

Country

Germany

Individual Site Status

Recruiting

Facility Name

Universitätsklinikum Gießen

City

Gießen

ZIP/Postal Code

35392

Country

Germany

Individual Site Status

Recruiting

Facility Name

Universitätsklinikum Leipzig

City

Leipzig

ZIP/Postal Code

04103

Country

Germany

Individual Site Status

Recruiting

Facility Name

Universitätsklinik Mannheim

City

Mannheim

ZIP/Postal Code

68167

Country

Germany

Individual Site Status

Recruiting

Facility Name

Deutsches Herzzentrum

City

München

ZIP/Postal Code

80636

Country

Germany

Individual Site Status

Recruiting

Facility Name

Klinikum Oldenburg

City

Oldenburg

ZIP/Postal Code

26133

Country

Germany

Individual Site Status

Recruiting

Facility Name

Herzzentrum Trier

City

Trier

ZIP/Postal Code

54292

Country

Germany

Individual Site Status

Recruiting

Facility Name

Universitätsklinikum Ulm

City

Ulm

ZIP/Postal Code

89070

Country

Germany

Individual Site Status

Recruiting

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

27578807

Citation

Ferenc M, Gick M, Comberg T, Rothe J, Valina C, Toma A, Loffelhardt N, Hochholzer W, Riede F, Kienzle RP, Achtari A, Neumann FJ. Culotte stenting vs. TAP stenting for treatment of de-novo coronary bifurcation lesions with the need for side-branch stenting: the Bifurcations Bad Krozingen (BBK) II angiographic trial. Eur Heart J. 2016 Dec 1;37(45):3399-3405. doi: 10.1093/eurheartj/ehw345. Epub 2016 Aug 30.

Results Reference

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26315736

Citation

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Results Reference

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19099943

Citation

Chen SL, Zhang JJ, Ye F, Chen YD, Lu SZ, Tan H, Patel T, Kenji K, Tamari I, Shan SJ, Zhu ZS, Lin S, Tian NL, Li XB, Liu ZZ, Lee M, Wei M, Xu YW, Yuan ZB, Qian J, Sun XW, Yang S, Chen JG, He B, Sumit S. [Comparison of DK crush with classical crush technique with drug-eluting stents for the treatment of coronary bifurcation lesions from DKCRUSH-1 study]. Zhonghua Xin Xue Guan Bing Za Zhi. 2008 Feb;36(2):100-7. Chinese.

Results Reference

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Citation

Chen SL, Santoso T, Zhang JJ, Ye F, Xu YW, Fu Q, Kan J, Paiboon C, Zhou Y, Ding SQ, Kwan TW. A randomized clinical study comparing double kissing crush with provisional stenting for treatment of coronary bifurcation lesions: results from the DKCRUSH-II (Double Kissing Crush versus Provisional Stenting Technique for Treatment of Coronary Bifurcation Lesions) trial. J Am Coll Cardiol. 2011 Feb 22;57(8):914-20. doi: 10.1016/j.jacc.2010.10.023.

Results Reference

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Citation

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Results Reference

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Citation

Ferenc M, Buettner HJ, Gick M, Comberg T, Rothe J, Khoury F, Valina C, Toma A, Kuebler P, Riede F, Neumann FJ. Clinical outcome after percutaneous treatment of de novo coronary bifurcation lesions using first or second generation of drug-eluting stents. Clin Res Cardiol. 2016 Mar;105(3):230-8. doi: 10.1007/s00392-015-0911-7. Epub 2015 Sep 2.

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Citation

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Results Reference

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

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