- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04192760
Culotte Versus DK-CRUSH Technique in Non-left Main Coronary Bifurcation Lesions (BBK-3)
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 Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Miroslaw Ferenc, MD
- Phone Number: 0049 7633 4020
- Email: miroslaw.ferenc@uniklinik-freiburg.de
Study Locations
-
-
-
Bad Oeynhausen, Germany, 32545
- Recruiting
- Herz-u. Diabeteszentrum
-
Bad Segeberg, Germany, 23795
- Recruiting
- Herz-Und Gefasszentrum
-
Dortmund, Germany, 44137
- Recruiting
- St. Johannes-Hospital
-
Dresden, Germany, 01307
- Recruiting
- Herzzentrum Dresden an der Technischen Universität
-
Essen, Germany, 45138
- Recruiting
- Elisabeth Krankenhaus
-
Gießen, Germany, 35392
- Recruiting
- Universitätsklinikum Gießen
-
Leipzig, Germany, 04103
- Recruiting
- Universitätsklinikum Leipzig
-
Mannheim, Germany, 68167
- Recruiting
- Universitätsklinik Mannheim
-
München, Germany, 80636
- Recruiting
- Deutsches Herzzentrum
-
Oldenburg, Germany, 26133
- Recruiting
- Klinikum Oldenburg
-
Trier, Germany, 54292
- Recruiting
- Herzzentrum Trier
-
Ulm, Germany, 89070
- Recruiting
- Universitatsklinikum Ulm
-
-
Suedring 15
-
Bad Krozingen, Suedring 15, Germany, 79189
- Recruiting
- University Heart Center Freiburg • Bad Krozingen
-
Contact:
- Miroslaw Ferenc, PD Dr.
- Phone Number: 0049 7633 4020
- Email: Miroslaw.Ferenc@universitaets-herzzentrum.de
-
Contact:
- Franz-Josef Neumann, Prof. Dr.
- Phone Number: 0049 7633 4020
- Email: Franz-Josef.Neumann@universitaets-herzzentrum.de
-
Principal Investigator:
- Miroslaw Ferenc, MD
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / 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, 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.
|
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 second re-wiring, a second kissing balloon-dilatation and final proximal optimization (POT) procedure (single short balloon inflation in proximal segment). |
Comparison of two technical approaches in the interventional treatment on de-novo non-left main coronary lesions
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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. |
9 months post index percutaneous coronary intervention (PCI)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Incidence of target lesion revascularisation (TLR)
Time Frame: 1 year
|
Any revascularisation (Re-PCI or CABG) at segments treated during index procedure
|
1 year
|
Incidence of major adverse cardiac events (MACE)
Time Frame: 1 year
|
MACE defined as death, Myocardial infarction (Q wave and Non-Q wave), emergent cardiac bypass surgery, or TLR
|
1 year
|
Incidence of binary restenosis at any segment of the bifurcation lesion
Time Frame: 9 months
|
≥ 50% diameter stenosis in the main and side branch
|
9 months
|
Incidence of binary restenosis in the main and side branch
Time Frame: 9 months
|
≥ 50% diameter stenosis in main and side branch
|
9 months
|
Incidence of stent thrombosis (ST)
Time Frame: 1 year
|
Post-procedure thrombotic stent occlusion according to the Academic Research Consortium-criteria
|
1 year
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Rate of device success
Time Frame: 9 months
|
Attainment of < 30% residual stenosis of the target lesion in the main and side branch
|
9 months
|
Mean procedure time
Time Frame: Index Intervention
|
Procedure time measured in minutes
|
Index Intervention
|
Mean radiation exposure
Time Frame: Index Intervention
|
Radiation exposure measured in cGym²
|
Index Intervention
|
Mean volume of used contrast medium
Time Frame: Index Intervention
|
Contrast medium measured in milliliters
|
Index Intervention
|
Collaborators and Investigators
Publications and helpful links
General Publications
- 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.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- UHZ Bad Krozingen-cathlab
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Coronary Stenosis
-
Biotronik (Beijing) Medical Device Ltd.Biotronik AGEnrolling by invitationNative Coronary Artery Stenosis | In-Stent Stenosis (Restenosis) of Coronary Artery StentChina
-
Axetis AGUnknownNative Coronary Artery StenosisNetherlands
-
Fundación Pública Andaluza Progreso y SaludUnknownUnprotected Left Main Coronary Artery StenosisSpain
-
ECRI bvBoston Scientific Corporation; Philips HealthcareActive, not recruitingLeft Main Coronary Artery StenosisSpain, United Kingdom, Italy
-
Institut Mutualiste MontsourisCompletedLeft Main Coronary Artery StenosisFrance
-
Tryton Medical, Inc.UnknownLeft Main Coronary Artery StenosisGermany
-
Columbia UniversityRecruitingLeft Anterior Descending Coronary Artery StenosisUnited States
-
San Luigi Gonzaga HospitalRecruitingCoronary Disease | STEMI | Coronary Artery Ectasia | Right Coronary Artery Occlusion | Right Coronary Artery StenosisSpain, Italy
-
Concept Medical Inc.Cardiovascular Research Foundation, New YorkNot yet recruitingCardiovascular Diseases | Coronary Artery Disease | Native Coronary Artery Stenosis
-
Das Radiologische ZentrumHeidelberg UniversityRecruiting
Clinical Trials on Stenting
-
Marco ValgimigliUnknownMyocardial InfarctionItaly
-
Catharina Ziekenhuis EindhovenTerminatedPeripheral Arterial Disease
-
Istanbul UniversityCompletedST-elevation Acute Myocardial InfarctionTurkey
-
Yonsei UniversityUnknownCholangiocarcinoma, Gallbladder Cancer, Pancreatic CancerKorea, Republic of
-
Istanbul Mehmet Akif Ersoy Educational and Training...Active, not recruitingCoronary Artery DiseaseTurkey
-
KCRISpectranetics CorporationTerminatedST Elevation Acute Myocardial InfarctionPoland
-
Fundacja Ośrodek Badań MedycznychTerminatedMyocardial Infarction | Coronary Artery DiseasePoland, Slovenia
-
Seoul National University HospitalSamsung Medical Center, Sungkyunkwan University School of Medicine; Ulsan University... and other collaboratorsUnknownStable AnginaKorea, Republic of, China
-
All India Institute of Medical Sciences, New DelhiCompletedGallbladder Cancer | Obstructive JaundiceIndia
-
Indiana UniversityRecruitingEsophageal Perforation | Esophageal FistulaUnited States