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

NCT ID: NCT01009996

Last Updated: 2020-02-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Study Classification

OBSERVATIONAL

Study Start Date

2009-10-31

Study Completion Date

2011-04-30

Brief Summary

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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

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Conditions

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Coronary Artery Disease Bifurcation Lesions

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Coronary bifurcation lesions

Kissing DEB

Intervention Type PROCEDURE

Provisional bare metal stenting followed by kissing drug-eluting balloons

Interventions

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Kissing DEB

Provisional bare metal stenting followed by kissing drug-eluting balloons

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Ospedale Santa Maria Goretti

OTHER

Sponsor Role lead

Responsible Party

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Gregory Sgueglia, MD

Principal investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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UOC Emodinamica e Cardiologia Interventistica - Ospedale Santa Maria Goretti

Latina, , Italy

Site Status

Countries

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Italy

References

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Sgueglia GA, Todaro D, Bisciglia A, Conte M, Stipo A, Pucci E. Kissing inflation is feasible with all second-generation drug-eluting balloons. Cardiovasc Revasc Med. 2011 Sep-Oct;12(5):280-5. doi: 10.1016/j.carrev.2010.12.001. Epub 2011 Jan 26.

Reference Type DERIVED
PMID: 21273144 (View on PubMed)

Other Identifiers

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SMG-003

Identifier Type: -

Identifier Source: org_study_id

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