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

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ClinicalTrials.gov Identifier: NCT01009996
Recruitment Status : Unknown
Verified November 2009 by Ospedale Santa Maria Goretti.
Recruitment status was:  Recruiting
First Posted : November 9, 2009
Last Update Posted : November 11, 2009
Sponsor:
Information provided by:
Ospedale Santa Maria Goretti

Study Description
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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

Condition or disease Intervention/treatment
Coronary Artery Disease Bifurcation Lesions Procedure: Kissing DEB

Study Design
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Study Type : Observational
Estimated Enrollment : 25 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Kissing Drug‐Eluting Balloons After Bare Metal Stenting of Coronary Bifurcation Lesions.
Study Start Date : October 2009
Estimated Primary Completion Date : February 2011
Estimated Study Completion Date : April 2011
Groups and Cohorts
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Group/Cohort Intervention/treatment
Coronary bifurcation lesions Procedure: Kissing DEB
Provisional bare metal stenting followed by kissing drug-eluting balloons


Outcome Measures
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Primary Outcome Measures :
  1. Late lumen loss on both MV and SB [ Time Frame: 9 months ]

Secondary Outcome Measures :
  1. Procedural success (residual stenosis <20% on MV and <50% on SB with TIMI flow 3 for both) [ Time Frame: immediate ]
  2. Binary restenosis rate [ Time Frame: 9 months ]
  3. Major adverse cardiac events [ Time Frame: 3 months ]
  4. Major adverse cardiac events [ Time Frame: 6 months ]
  5. Major adverse cardiac events [ Time Frame: 9 months ]
  6. Major adverse cardiac events [ Time Frame: 12 months ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
All coming
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01009996


Contacts
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Contact: Gregory A Sgueglia, MD g.a.sgueglia@gmail.com
Contact: Daniel Todaro, MD danieltodaro@libero.it

Locations
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Italy
UOC Emodinamica e Cardiologia Interventistica - Ospedale Santa Maria Goretti Recruiting
Latina, Italy, 04100
Contact: Gregory A Sgueglia, MD       g.a.sgueglia@gmail.com   
Contact: Daniel Todaro, MD       danieltodaro@libero.it   
Sponsors and Collaborators
Ospedale Santa Maria Goretti
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Edoardo Pucci, UOC Emodinamica e Cardiologia Interventistica - Ospedale Santa Maria Goretti
ClinicalTrials.gov Identifier: NCT01009996     History of Changes
Other Study ID Numbers: SMG-003
First Posted: November 9, 2009    Key Record Dates
Last Update Posted: November 11, 2009
Last Verified: November 2009
Keywords provided by Ospedale Santa Maria Goretti:
Coronary bifurcation lesions
Additional relevant MeSH terms:
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Coronary Artery Disease
Coronary Disease
Myocardial Ischemia
Heart Diseases
 Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases