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

Coronary Artery Disease Clinical Trial

— KISSING DEBBIE  

Official title:

Kissing Drug‐Eluting Balloons After Bare Metal Stenting of Coronary Bifurcation Lesions.

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01009996
• Other study ID #: SMG-003
• Status: Withdrawn
• Start date: October 2009
• Est. completion date: April 2011

Study information

• Verified date: February 2020
• Source: Ospedale Santa Maria Goretti
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: April 2011
• Est. primary completion date: February 2011
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Bifurcation Lesions
• Coronary Artery Disease

Intervention

Procedure:
• Kissing DEB
Provisional bare metal stenting followed by kissing drug-eluting balloons

Locations

Country	Name	City	State
Italy	UOC Emodinamica e Cardiologia Interventistica - Ospedale Santa Maria Goretti	Latina

Sponsors (1)

Lead Sponsor	Collaborator
Ospedale Santa Maria Goretti

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Late lumen loss on both MV and SB		9 months
Secondary	Procedural success (residual stenosis <20% on MV and <50% on SB with TIMI flow 3 for both)		immediate
Secondary	Binary restenosis rate		9 months
Secondary	Major adverse cardiac events		3 months
Secondary	Major adverse cardiac events		6 months
Secondary	Major adverse cardiac events		9 months
Secondary	Major adverse cardiac events		12 months