NCT01009996

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

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Oct 2009

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2009

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

November 6, 2009

Completed
3 days until next milestone

First Posted

Study publicly available on registry

November 9, 2009

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2011

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2011

Completed
Last Updated

February 25, 2020

Status Verified

February 1, 2020

Enrollment Period

1.3 years

First QC Date

November 6, 2009

Last Update Submit

February 21, 2020

Conditions

Coronary Artery DiseaseBifurcation Lesions

Keywords

Coronary bifurcation lesions

Outcome Measures

Primary Outcomes (1)

  • Late lumen loss on both MV and SB

    9 months

Secondary Outcomes (6)

  • Procedural success (residual stenosis <20% on MV and <50% on SB with TIMI flow 3 for both)

    immediate

  • Binary restenosis rate

    9 months

  • Major adverse cardiac events

    3 months

  • Major adverse cardiac events

    6 months

  • Major adverse cardiac events

    9 months

  • +1 more secondary outcomes

Study Arms (1)

Coronary bifurcation lesions

Procedure: Kissing DEB

Interventions

Kissing DEBPROCEDURE

Provisional bare metal stenting followed by kissing drug-eluting balloons

Coronary bifurcation lesions

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

All coming

You may qualify if:

  • Age \>18 years
  • De novo major bifurca6on lesion of the left coronary artery (LAD-D; LCX-OM)
  • RVD 2.25-4.0 mm

You may not qualify if:

  • LMCA
  • AMI within 48 hours
  • Limited compliance with 3-month dual antiplatelet therapy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UOC Emodinamica e Cardiologia Interventistica - Ospedale Santa Maria Goretti

Latina, 04100, Italy

Location

Related Publications (1)

  • 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.

    PMID: 21273144DERIVED

MeSH Terms

Conditions

Coronary Artery Disease

Condition Hierarchy (Ancestors)

Coronary DiseaseMyocardial IschemiaHeart DiseasesCardiovascular DiseasesArteriosclerosisArterial Occlusive DiseasesVascular Diseases
0

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal investigator

Study Record Dates

First Submitted

November 6, 2009

First Posted

November 9, 2009

Study Start

October 1, 2009

Primary Completion

February 1, 2011

Study Completion

April 1, 2011

Last Updated

February 25, 2020

Record last verified: 2020-02

Locations

IT(1)