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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

Tracking Information
First Submitted Date November 6, 2009
First Posted Date November 9, 2009
Last Update Posted Date November 11, 2009
Study Start Date October 2009
Estimated Primary Completion Date February 2011   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: November 6, 2009)
Late lumen loss on both MV and SB [ Time Frame: 9 months ]
Original Primary Outcome Measures Same as current
Change History Complete list of historical versions of study NCT01009996 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures
 (submitted: November 6, 2009)
  • Procedural success (residual stenosis <20% on MV and <50% on SB with TIMI flow 3 for both) [ Time Frame: immediate ]
  • Binary restenosis rate [ Time Frame: 9 months ]
  • Major adverse cardiac events [ Time Frame: 3 months ]
  • Major adverse cardiac events [ Time Frame: 6 months ]
  • Major adverse cardiac events [ Time Frame: 9 months ]
  • Major adverse cardiac events [ Time Frame: 12 months ]
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Efficacy Study of Kissing Drug‐Eluting Balloons in Coronary Bifurcation Lesions
Official Title Kissing Drug‐Eluting Balloons After Bare Metal Stenting of 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
Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population All coming
Condition
  • Coronary Artery Disease
  • Bifurcation Lesions
Intervention Procedure: Kissing DEB
Provisional bare metal stenting followed by kissing drug-eluting balloons
Study Groups/Cohorts Coronary bifurcation lesions
Intervention: Procedure: Kissing DEB
Publications * 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Unknown status
Estimated Enrollment
 (submitted: November 6, 2009)
25
Original Estimated Enrollment Same as current
Estimated Study Completion Date April 2011
Estimated Primary Completion Date February 2011   (Final data collection date for primary outcome measure)
Eligibility 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
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Italy
Removed Location Countries  
 
Administrative Information
NCT Number NCT01009996
Other Study ID Numbers SMG-003
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Edoardo Pucci, UOC Emodinamica e Cardiologia Interventistica - Ospedale Santa Maria Goretti
Study Sponsor Ospedale Santa Maria Goretti
Collaborators Not Provided
Investigators Not Provided
PRS Account Ospedale Santa Maria Goretti
Verification Date November 2009