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

Coronary Stenosis Clinical Trial

— 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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04192760
• Other study ID #: UHZ Bad Krozingen-cathlab
• Status: Recruiting
• Phase: N/A
• Start date: December 1, 2019
• Est. completion date: December 31, 2023

Study information

• Verified date: August 2022
• Source: University Heart Center Freiburg - Bad Krozingen
• Contact: Miroslaw Ferenc, MD
• Phone: 0049 7633 4020
• Email: miroslaw.ferenc[@]uniklinik-freiburg.de
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 400
• Est. completion date: December 31, 2023
• Est. primary completion date: March 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. 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).

2. Clinical indication to perform double stenting only with Synergy™ stents for a clinically 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 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.

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 stent implantation.

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 and has written informed consent as approved by the Ethics Committee.

8. Patient is willing to comply with all required post-procedure follow-up.

Exclusion Criteria:

1. Patient had an acute ST-elevation myocardial infarction within 72 h preceding the index procedure or target vessel contains intraluminal thrombus.

2. Use of any other coronary stent than Synergy™ and Synergy Megatron™ except for baiI-out situations.

3. Patient with a known hypersensitivity or contraindication to the needed antithrombotic therapy, 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 noncompliant with 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.

Related Conditions & MeSH terms

• Constriction, Pathologic
• Coronary Stenosis
• Stent Stenosis

Intervention

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

Locations

Country	Name	City	State
Germany	University Heart Center Freiburg • Bad Krozingen	Bad Krozingen	Suedring 15
Germany	Herz-u. Diabeteszentrum	Bad Oeynhausen
Germany	Herz-und Gefäßzentrum	Bad Segeberg
Germany	St. Johannes-Hospital	Dortmund
Germany	Herzzentrum Dresden an der Technischen Universität	Dresden
Germany	Elisabeth Krankenhaus	Essen
Germany	Universitätsklinikum Gießen	Gießen
Germany	Universitätsklinikum Leipzig	Leipzig
Germany	Universitätsklinik Mannheim	Mannheim
Germany	Deutsches Herzzentrum	München
Germany	Klinikum Oldenburg	Oldenburg
Germany	Herzzentrum Trier	Trier
Germany	Universitätsklinikum Ulm	Ulm

Sponsors (1)

Lead Sponsor	Collaborator
University Heart Center Freiburg - Bad Krozingen

Country where clinical trial is conducted

Germany, 

References & Publications (7)

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 (D — View Citation

Chen SL, Xu B, Han YL, Sheiban I, Zhang JJ, Ye F, Kwan TW, Paiboon C, Zhou YJ, Lv SZ, Dangas GD, Xu YW, Wen SY, Hong L, Zhang RY, Wang HC, Jiang TM, Wang Y, Sansoto T, Chen F, Yuan ZY, Li WM, Leon MB. Clinical Outcome After DK Crush Versus Culotte Stentin — View Citation

Chen SL, Zhang JJ, Ye F, Chen YD, Lü 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 techniqu — View Citation

Erglis A, Kumsars I, Niemelä M, Kervinen K, Maeng M, Lassen JF, Gunnes P, Stavnes S, Jensen JS, Galløe A, Narbute I, Sondore D, Mäkikallio T, Ylitalo K, Christiansen EH, Ravkilde J, Steigen TK, Mannsverk J, Thayssen P, Hansen KN, Syvänne M, Helqvist S, Kj — View 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. C — View Citation

Ferenc M, Gick M, Comberg T, Rothe J, Valina C, Toma A, Löffelhardt 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 — View Citation

Lee JM, Hahn JY, Kang J, Park KW, Chun WJ, Rha SW, Yu CW, Jeong JO, Jeong MH, Yoon JH, Jang Y, Tahk SJ, Gwon HC, Koo BK, Kim HS. Differential Prognostic Effect Between First- and Second-Generation Drug-Eluting Stents in Coronary Bifurcation Lesions: Patie — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Rate of device success	Attainment of < 30% residual stenosis of the target lesion in the main and side branch	9 months
Other	Mean procedure time	Procedure time measured in minutes	Index Intervention
Other	Mean radiation exposure	Radiation exposure measured in cGym²	Index Intervention
Other	Mean volume of used contrast medium	Contrast medium measured in milliliters	Index Intervention
Primary	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.	9 months post index percutaneous coronary intervention (PCI)
Secondary	Incidence of target lesion revascularisation (TLR)	Any revascularisation (Re-PCI or CABG) at segments treated during index procedure	1 year
Secondary	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	1 year
Secondary	Incidence of binary restenosis at any segment of the bifurcation lesion	= 50% diameter stenosis in the main and side branch	9 months
Secondary	Incidence of binary restenosis in the main and side branch	= 50% diameter stenosis in main and side branch	9 months
Secondary	Incidence of stent thrombosis (ST)	Post-procedure thrombotic stent occlusion according to the Academic Research Consortium-criteria	1 year