Efficacy Study of Kissing Drug-Eluting Balloons in Coronary Bifurcation Lesions

Withdrawn

• Conditions: Coronary Artery Disease; Bifurcation Lesions
• Interventions: Procedure: Kissing DEB

• Registration Number: NCT01009996
• Lead Sponsor: Ospedale Santa Maria Goretti

Brief Summary

KISSING DEBBIE's aim at assessing angiographic and clinical outcomes of provisional treatment of coronary bifurca6on lesions according to TAP sten6ng with BMS and final kissing DEB

Detailed Description

Not available

Study Timeline

• Study Start: 2009-10
• Study First Submitted: 2009-11-06
• Study First Submitted QC: 2009-11-06
• Study First Posted: 2009-11-09
• Primary Completion: 2011-02
• Study Completion: 2011-04
• Status Verified: 2020-02
• Last Update Submitted: 2020-02-21
• Last Update Posted: 2020-02-25

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

• Age >18 years
• De novo major bifurca6on lesion of the left coronary artery (LAD-D; LCX-OM)
• RVD 2.25-4.0 mm

Exclusion Criteria

• LMCA
• AMI within 48 hours
• Limited compliance with 3-month dual antiplatelet therapy

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Coronary bifurcation lesions	Kissing DEB	-

Primary Outcome Measures

Name	Time	Method
Late lumen loss on both MV and SB	9 months

Secondary Outcome Measures

Name	Time	Method
Binary restenosis rate	9 months
Procedural success (residual stenosis <20% on MV and <50% on SB with TIMI flow 3 for both)	immediate
Major adverse cardiac events	12 months

Trial Locations

Locations (1)

UOC Emodinamica e Cardiologia Interventistica - Ospedale Santa Maria Goretti; 🇮🇹 Latina, Italy