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

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

Status

Withdrawn

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01009996

Acronym

KISSING DEBBIE

Enrollment

Registered

2009-11-09

Start date

2009-10-31

Completion date

2011-04-30

Last updated

2020-02-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Bifurcation Lesions, Coronary Artery Disease

Keywords

Coronary bifurcation lesions

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

Interventions

PROCEDUREKissing DEB

Provisional bare metal stenting followed by kissing drug-eluting balloons

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Late lumen loss on both MV and SB	9 months

Secondary

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

Countries

Italy

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 29, 2026