Culotte Versus DK-CRUSH Technique in Non-left Main Coronary Bifurcation Lesions
NCT ID: NCT04192760
Last Updated: 2022-08-05
Study Results
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Basic Information
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UNKNOWN
NA
400 participants
INTERVENTIONAL
2019-12-01
2023-12-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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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, 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.
Stenting
Comparison of two technical approaches in the interventional treatment on de-novo non-left main coronary lesions
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 second re-wiring, a second kissing balloon-dilatation and final proximal optimization (POT) procedure (single short balloon inflation in proximal segment).
Stenting
Comparison of two technical approaches in the interventional treatment on de-novo non-left main coronary lesions
Interventions
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Stenting
Comparison of two technical approaches in the interventional treatment on de-novo non-left main coronary lesions
Eligibility Criteria
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Inclusion Criteria
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
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.
18 Years
ALL
No
Sponsors
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University Heart Center Freiburg - Bad Krozingen
OTHER
Responsible Party
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Dr. Miroslaw FERENC
Director of interventional cardiology department
Locations
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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, , Germany
Countries
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Central Contacts
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Facility Contacts
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References
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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.
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.
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.
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.
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.
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.
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.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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UHZ Bad Krozingen-cathlab
Identifier Type: -
Identifier Source: org_study_id
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