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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01009996
Recruitment Status : Withdrawn (Funding issues)
First Posted : November 9, 2009
Last Update Posted : February 25, 2020
Sponsor:
Information provided by (Responsible Party):
Gregory Sgueglia, MD, Ospedale Santa Maria Goretti

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

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Study Type : Observational
Actual Enrollment : 0 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Kissing Drug-Eluting Balloons After Bare Metal Stenting of Coronary Bifurcation Lesions.
Estimated Study Start Date : October 2009
Estimated Primary Completion Date : February 2011
Estimated Study Completion Date : April 2011

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




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 ]


Information from the National Library of Medicine

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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

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


Locations
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Italy
UOC Emodinamica e Cardiologia Interventistica - Ospedale Santa Maria Goretti
Latina, Italy, 04100
Sponsors and Collaborators
Ospedale Santa Maria Goretti
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Gregory Sgueglia, MD, Principal investigator, Ospedale Santa Maria Goretti
ClinicalTrials.gov Identifier: NCT01009996    
Other Study ID Numbers: SMG-003
First Posted: November 9, 2009    Key Record Dates
Last Update Posted: February 25, 2020
Last Verified: February 2020
Keywords provided by Gregory Sgueglia, MD, 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