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

NCT04192760 | Unknown

• 1 other identifier: UHZ Bad Krozingen-cathlab
• Study Type: interventional
• Target: 400
• Locations: 1 country
• Sites: 13

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

Conditions

Coronary Stenosis; Stent Stenosis

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Incidence of target lesion revascularisation (TLR)

  1 year

• Incidence of major adverse cardiac events (MACE)

  1 year

• Incidence of binary restenosis at any segment of the bifurcation lesion

  9 months

• Incidence of binary restenosis in the main and side branch

  9 months

• Incidence of stent thrombosis (ST)

  1 year

Other Outcomes (4)

• Rate of device success

  9 months

• Mean procedure time

  Index Intervention

• Mean radiation exposure

  Index Intervention

Study Arms (2)

Culotte Technique

ACTIVE COMPARATOR

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.

Procedure: Stenting

DK-Crush Technique

ACTIVE COMPARATOR

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).

Procedure: Stenting

Interventions

Stenting PROCEDURE

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

Culotte Technique; DK-Crush Technique

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University Heart Center Freiburg - Bad Krozingen: lead

Study Sites (13)

University Heart Center Freiburg • Bad Krozingen

Bad Krozingen, Suedring 15, 79189, Germany

RECRUITING

Herz-u. Diabeteszentrum

Bad Oeynhausen, 32545, Germany

RECRUITING

Herz-und Gefäßzentrum

Bad Segeberg, 23795, Germany

RECRUITING

St. Johannes-Hospital

Dortmund, 44137, Germany

RECRUITING

Herzzentrum Dresden an der Technischen Universität

Dresden, 01307, Germany

RECRUITING

Elisabeth Krankenhaus

Essen, 45138, Germany

RECRUITING

Universitätsklinikum Gießen

Giessen, 35392, Germany

RECRUITING

Universitätsklinikum Leipzig

Leipzig, 04103, Germany

RECRUITING

Universitätsklinik Mannheim

Mannheim, 68167, Germany

RECRUITING

Deutsches Herzzentrum

München, 80636, Germany

RECRUITING

Klinikum Oldenburg

Oldenburg, 26133, Germany

RECRUITING

Herzzentrum Trier

Trier, 54292, Germany

RECRUITING

Universitätsklinikum Ulm

Ulm, 89070, Germany

RECRUITING

Related Publications (7)

• 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.

  PMID: 27578807 RESULT

• 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 Stenting of Distal Left Main Bifurcation Lesions: The 3-Year Follow-Up Results of the DKCRUSH-III Study. JACC Cardiovasc Interv. 2015 Aug 24;8(10):1335-1342. doi: 10.1016/j.jcin.2015.05.017.

  PMID: 26315736 RESULT

• 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.

  PMID: 19099943 RESULT

• 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.

  PMID: 21329837 RESULT

• Erglis A, Kumsars I, Niemela M, Kervinen K, Maeng M, Lassen JF, Gunnes P, Stavnes S, Jensen JS, Galloe A, Narbute I, Sondore D, Makikallio T, Ylitalo K, Christiansen EH, Ravkilde J, Steigen TK, Mannsverk J, Thayssen P, Hansen KN, Syvanne M, Helqvist S, Kjell N, Wiseth R, Aaroe J, Puhakka M, Thuesen L; Nordic PCI Study Group. Randomized comparison of coronary bifurcation stenting with the crush versus the culotte technique using sirolimus eluting stents: the Nordic stent technique study. Circ Cardiovasc Interv. 2009 Feb;2(1):27-34. doi: 10.1161/CIRCINTERVENTIONS.108.804658. Epub 2009 Feb 10.

  PMID: 20031690 RESULT

• 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.

  PMID: 26329585 RESULT

• 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: Patient-Level Analysis of the Korean Bifurcation Pooled Cohorts. JACC Cardiovasc Interv. 2015 Aug 24;8(10):1318-1331. doi: 10.1016/j.jcin.2015.05.014.

  PMID: 26315734 RESULT

MeSH Terms

Conditions

Coronary Stenosis

Interventions

Stents

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases

Intervention Hierarchy (Ancestors)

Prostheses and Implants; Equipment and Supplies

Central Study Contacts

Miroslaw Ferenc, MD

CONTACT

0049 7633 4020; miroslaw.ferenc@uniklinik-freiburg.de

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of interventional cardiology department

Study Record Dates

• First Submitted: November 27, 2019
• First Posted: December 10, 2019
• Study Start: December 1, 2019
• Primary Completion: March 31, 2023
• Study Completion: December 31, 2023
• Last Updated: August 5, 2022

Record last verified: 2022-08

Data Sharing

• IPD Sharing: Will not share

Locations

DE (13)