Coronary Artery DiseaseKISSING DEBBIENCT01009996
Efficacy Study of Kissing Drug-Eluting Balloons in Coronary Bifurcation Lesions
An observational study of Coronary Artery Disease and Bifurcation Lesions, run by Ospedale Santa Maria Goretti at 1 site in Italy.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coronary Artery Disease, Bifurcation Lesions
- What is being tested?
- Kissing DEB
- Type of treatment
- Surgery or procedure
- How many people
- 0 participants
- Where
- 1 siteItaly
- Study dates
- Oct 2009to Apr 2011
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All coming
Who may be able to join
- Age >18 years
- De novo major bifurca6on lesion of the left coronary artery (LAD-D; LCX-OM)
- RVD 2.25-4.0 mm
Who cannot join
- LMCA
- AMI within 48 hours
- Limited compliance with 3-month dual antiplatelet therapy
Trial locations and contacts
1 site in 1 country.
Italy1 site
UOC Emodinamica e Cardiologia Interventistica - Ospedale Santa Maria Goretti
Latina, 04100
About this study
Official title: Kissing Drug-Eluting Balloons After Bare Metal Stenting of Coronary Bifurcation Lesions.
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
- Conditions
- Coronary Artery Disease, Bifurcation Lesions
- Being tested
- Kissing DEB
- Keywords
- Coronary bifurcation lesions
- Medical subject headings
- Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Kissing DEBProcedure or surgery
Provisional bare metal stenting followed by kissing drug-eluting balloons
| Study group | Role | What they receive |
|---|---|---|
| Coronary bifurcation lesions | Not described Receives: Procedure: Kissing DEB |
What is being measured
The primary outcome is the main question the study is designed to answer.
Late lumen loss on both MV and SB
Measured: 9 months
Secondary outcomes (6)
Procedural success (residual stenosis <20% on MV and <50% on SB with TIMI flow 3 for both)
Measured: immediate
Binary restenosis rate
Measured: 9 months
Major adverse cardiac events
Measured: 3 months
Major adverse cardiac events
Measured: 6 months
Major adverse cardiac events
Measured: 9 months
Major adverse cardiac events
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Nov 2009 (estimated)
- Study startOct 2009 (estimated)
- Primary completionFeb 2011 (estimated)
- Study completionApr 2011 (estimated)
Why it stopped: Funding issues
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Coronary Artery DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ospedale Santa Maria Goretti
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gregory Sgueglia, MD, Ospedale Santa Maria Goretti
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01009996
- Sponsor's protocol ID
- SMG-003
- Acronym
- KISSING DEBBIE
- Status last verified
- Feb 2020
- First submitted
- 6 Nov 2009
- Last updated
- 25 Feb 2020
- Results posted
- No
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.
PubMed 21273144
Study at a glance
From the registry record, last updated by the sponsor on 25 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Kissing Drug-Eluting Balloons After Bare Metal Stenting of Coronary Bifurcation Lesions.
- ClinicalTrials.gov ID
- NCT01009996
- Acronym / sponsor ID
- KISSING DEBBIE / SMG-003
- Conditions
- Coronary Artery Disease, Bifurcation Lesions
- Keywords
- Coronary bifurcation lesions
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: Funding issues
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Ospedale Santa Maria GorettiUniversity, hospital or other
- Study start
- Oct 2009 (estimated)
- Primary completion
- Feb 2011 (estimated)
- Study completion
- Apr 2011 (estimated)
- First posted
- 9 Nov 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Coronary bifurcation lesions | – | Procedure: Kissing DEB |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All coming
Key inclusion criteria (3 listed)
- Age >18 years
- De novo major bifurca6on lesion of the left coronary artery (LAD-D; LCX-OM)
- RVD 2.25-4.0 mm
Key exclusion criteria (3 listed)
- LMCA
- AMI within 48 hours
- Limited compliance with 3-month dual antiplatelet therapy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Kissing DEBProvisional bare metal stenting followed by kissing drug-eluting balloons | Procedure or surgery | Coronary bifurcation lesions |
Primary outcome
Late lumen loss on both MV and SB
Time frame: 9 months
6 secondary outcomes
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
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Feb 2020.
- Derived from this study: PubMed 21273144Sgueglia 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Coronary Artery Disease and Bifurcation Lesions, run by Ospedale Santa Maria Goretti at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 25 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Late lumen loss on both MV and SB (time frame: 9 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01009996, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Feb 2020.