Culotte Versus DK-CRUSH Technique in Non-left Main Coronary Bifurcation Lesions (NCT04192760) | Clinical Trial Compass
UnknownNot Applicable
Culotte Versus DK-CRUSH Technique in Non-left Main Coronary Bifurcation Lesions
Germany400 participantsStarted 2019-12-01
Plain-language 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
Who can participate
Age range18 Years
SexALL
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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.
What they're measuring
1
Angiographic restenosis in the bifurcation lesion by quantitative coronary analysis (QCA)
Timeframe: 9 months post index percutaneous coronary intervention (PCI)
Trial details
NCT IDNCT04192760
SponsorUniversity Heart Center Freiburg - Bad Krozingen
✕. 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.