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

Launched by UNIVERSITY HEART CENTER FREIBURG - BAD KROZINGEN · Dec 9, 2019

Keywords

ClinConnect Summary

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...

Gender

ALL

Eligibility criteria

• 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.