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

• Sponsor: Ospedale Santa Maria Goretti (Other)
• Overall Status: Withdrawn
• CT.gov ID: NCT01009996
• Collaborator: (none)
• Enrollment: 0
• Location: 1
• Anticipated Duration (Months): 18
• Patients Per Site Per Month: 0

Study Details

Study Description

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	Phase
Coronary Artery Disease; Bifurcation Lesions	Procedure: Kissing DEB

Study Design

• 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.
• Anticipated Study Start Date: Oct 1, 2009
• Anticipated Primary Completion Date: Feb 1, 2011
• Anticipated Study Completion Date: Apr 1, 2011

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Late lumen loss on both MV and SB [9 months]

Secondary Outcome Measures

1. Procedural success (residual stenosis <20% on MV and <50% on SB with TIMI flow 3 for both) [immediate]

2. Binary restenosis rate [9 months]

3. Major adverse cardiac events [3 months]

4. Major adverse cardiac events [6 months]

5. Major adverse cardiac events [9 months]

6. Major adverse cardiac events [12 months]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Locations

	Site	City	State	Country	Postal Code
1	UOC Emodinamica e Cardiologia Interventistica - Ospedale Santa Maria Goretti	Latina		Italy	04100

Sponsors and Collaborators

• Ospedale Santa Maria Goretti

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Gregory Sgueglia, MD, Principal investigator, Ospedale Santa Maria Goretti
• ClinicalTrials.gov Identifier: NCT01009996
• Other Study ID Numbers: SMG-003
• First Posted: Nov 9, 2009
• Last Update Posted: Feb 25, 2020
• Last Verified: Feb 1, 2020

• Keywords provided by Gregory Sgueglia, MD, Principal investigator, Ospedale Santa Maria Goretti: Coronary bifurcation lesions
• Additional relevant MeSH terms: Coronary Artery Disease

Study Results

No Results Posted as of Feb 25, 2020