Efficacy Study of Kissing Drug-Eluting Balloons in Coronary Bifurcation Lesions (KISSING DEBBIE)

February 21, 2020 updated by: Gregory Sgueglia, MD, Ospedale Santa Maria Goretti

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

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

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Study Type

Observational

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Latina, Italy, 04100
        • UOC Emodinamica e Cardiologia Interventistica - Ospedale Santa Maria Goretti

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

All coming

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Coronary bifurcation lesions
Procedure: Kissing DEB
Provisional bare metal stenting followed by kissing drug-eluting balloons

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Late lumen loss on both MV and SB
Time Frame: 9 months
9 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Procedural success (residual stenosis <20% on MV and <50% on SB with TIMI flow 3 for both)
Time Frame: immediate
immediate
Binary restenosis rate
Time Frame: 9 months
9 months
Major adverse cardiac events
Time Frame: 3 months
3 months
Major adverse cardiac events
Time Frame: 6 months
6 months
Major adverse cardiac events
Time Frame: 9 months
9 months
Major adverse cardiac events
Time Frame: 12 months
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ospedale Santa Maria Goretti

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

October 1, 2009

Primary Completion (Anticipated)

February 1, 2011

Study Completion (Anticipated)

April 1, 2011

Study Registration Dates

First Submitted

November 6, 2009

First Submitted That Met QC Criteria

November 6, 2009

First Posted (Estimate)

November 9, 2009

Study Record Updates

Last Update Posted (Actual)

February 25, 2020

Last Update Submitted That Met QC Criteria

February 21, 2020

Last Verified

February 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SMG-003

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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