Coronary Artery DiseaseNCT02364778

Single-centre, Registry Trial, the Patients Presented With Stable Coronary Artery Disease

An observational study of Coronary Artery Disease, run by Icahn School of Medicine at Mount Sinai at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 to 90 years
Conditions the study is for: Coronary Artery Disease
How many people: 30 participants
Where: 1 siteUnited States
Study dates: Dec 2014to May 2015
How long will I take part?: 1 Year
Phase: Observational
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 to 90 years
All sexes
No healthy volunteers
Adult, Older adult

Study population: Patients with stable coronary artery disease with angiographic main vessel lesion not involving side branch (SB) in whom provisional stenting strategy is planned

Who may be able to join

Over 18 years of age presenting with stable coronary artery disease.
Angiographic lesion not involving side branch (SB) in whom provisional main vessel stenting strategy is planned after reviewing angiogram will be recruited

Who cannot join

Patient with lesion involving side branch ( >70 %) by angiogram and need pre-dilation.
Patients with ostial left main artery lesions or ostial right coronary artery lesions
Female patients with child bearing potential not taking adequate contraceptives or currently breastfeeding
Known allergy to acetylsalicylic acid or clopidogrel.
Planned surgery within 12 months.
History of bleeding diathesis

Show all 9Show fewer

Major surgery within 15 days
Life expectancy < 12 months.
Patients with kidney dysfunction (CrCl<30)

Trial locations and contacts

1 site in 1 country.

United States1 site

Icahn School of Medicine at Mount Sinai
New York, New York, 10029

Other trials in United States

About this study

Official title: ORBID Trial: Three-Dimensional (3D) Optical Coherence Tomography Guided Assessment of Side Branch Vessel After Provisional Main Vessel Stenting in Coronary Artery Stenting

This is a prospective study to analyze the outcome of provisional main vessel stenting on side branch by utilizing Two-Dimensional (2D) and Three-Dimensional (3D) frequency domain optical coherence tomography (FD-OCT). To analyze the fate of side-branch after provisional main vessel stenting based on morphology defined prior to PCI by OCT. Offline analysis of side branch impingement of the ostium of SB leading to acute loss in SB diameter area, carina shift and plaque shift will be also be performed.

Read the detailed description

Patients with stable coronary artery disease with angiographic main vessel lesion not involving side branch (SB) in whom provisional stenting strategy is planned will be recruited. All the participants of the registry will receive same stent. OCT will be performed to analyze plaque morphology, SB size, SB angle and side branch ostial involvement.

Conditions: Coronary Artery Disease
Keywords: CAD
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.

Study groups in NCT02364778
Study group	Role	What they receive
Provisional stenting strategy		Patients with stable coronary artery disease with angiographic main vessel lesion not involving side branch (SB) in whom provisional stenting strategy is planned.

What is being measured

The primary outcome is the main question the study is designed to answer.

MLD SB Diameter
Optical coherence tomography (OCT) - a high resolution intravascular imaging technique to assess side branch size. Side branch diameter will be measured by QAngio OCT software from Medis. Three-Dimensional Quantitative Coronary Angiography (3D-QCA) Analysis of Bifurcation Lesions Before (PRE) and After (POST) Provisional Stenting. Main vessel minimal lumen diameter (MLD)
Measured: day 1

Secondary outcomes (3)

SB Angle
Optical coherence tomography - a high resolution intravascular imaging technique to assess side branch (SB) angle. Side branch angle will be measured by QAngio XA 3D software (Medis). Three-Dimensional Quantitative Coronary Angiography (3D-QCA) Analysis of Bifurcation Lesions Before (PRE) and After (POST) Provisional Stenting. Bifurcation angles (BA)
Measured: day 1
SB Ostial Involvement
Optical coherence tomography - a high resolution intravascular imaging technique to assess side branch ostial involvement. Side branch area will be measured by QAngio OCT software (Medis). Three-Dimensional Quantitative Coronary Angiography (3D-QCA) Analysis of Bifurcation Lesions Before (PRE) and After (POST) Provisional Stenting. Minimal lumen diameter (MLD)
Measured: day 1
Diameter Stenosis (DS)
Three-Dimensional Quantitative Coronary Angiography (3D-QCA) Analysis of Bifurcation Lesions Before (PRE) and After (POST) Provisional Stenting. Side Branch Ostium Diameter Stenosis (DS).
Measured: day 1

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Dec 2014May 2015

First posted18 Feb 2015 (estimated)
Study startDec 2014
Primary completionMay 2015
Study completionMay 2015

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Coronary Artery DiseaseStudies of the same condition, open and under way.
More trials run by Icahn School of Medicine at Mount SinaiThe sponsor's other registered studies.
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: 30 participants (actual)
Target duration: 1 Year

IDs, dates and publications

ClinicalTrials.gov ID: NCT02364778
Sponsor's protocol ID: GCO 14-1777
Status last verified: May 2016
First submitted: 10 Feb 2015
Last updated: 7 Jul 2016
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Publications

Kini AS, Vengrenyuk Y, Pena J, Yoshimura T, Panwar SR, Motoyama S, Kezbor S, Hasan CM, Palkhiwala S, Kovacic JC, Moreno P, Baber U, Mehran R, Narula J, Sharma SK. Plaque morphology predictors of side branch occlusion after provisional stenting in coronary bifurcation lesion: Results of optical coherence tomography bifurcation study (ORBID). Catheter Cardiovasc Interv. 2017 Feb 1;89(2):259-268. doi: 10.1002/ccd.26524. Epub 2016 Mar 31.
PubMed 27029714

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 7 Jul 2016. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: ORBID Trial: Three-Dimensional (3D) Optical Coherence Tomography Guided Assessment of Side Branch Vessel After Provisional Main Vessel Stenting in Coronary Artery Stenting
ClinicalTrials.gov ID: NCT02364778
Acronym / sponsor ID: GCO 14-1777
Conditions: Coronary Artery Disease
Keywords: CAD
Study type: Observational
Recruitment status: Completed
Enrolment: 30 participants (actual)
Lead sponsor: Icahn School of Medicine at Mount SinaiUniversity, hospital or other
Collaborators: Boston Scientific Corporation
Study start: Dec 2014
Primary completion: May 2015 (actual)
Study completion: May 2015 (actual)
First posted: 18 Feb 2015 (estimated)
Results: Posted 7 Jul 2016

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Observational model: Cohort
Time perspective: Prospective
Target follow-up: 1 Year
Number of arms: 1

Arm	Type	Receives
Provisional stenting strategy	–	–Patients with stable coronary artery disease with angiographic main vessel lesion not involving side branch (SB) in whom provisional stenting strategy is planned.

Who may qualify

Ages: 18 to 90 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult
Study population: Patients with stable coronary artery disease with angiographic main vessel lesion not involving side branch (SB) in whom provisional stenting strategy is planned

Key inclusion criteria (2 listed)

Over 18 years of age presenting with stable coronary artery disease.
Angiographic lesion not involving side branch (SB) in whom provisional main vessel stenting strategy is planned after reviewing angiogram will be recruited

Key exclusion criteria (9 listed)

Patient with lesion involving side branch ( >70 %) by angiogram and need pre-dilation.
Patients with ostial left main artery lesions or ostial right coronary artery lesions
Female patients with child bearing potential not taking adequate contraceptives or currently breastfeeding
Known allergy to acetylsalicylic acid or clopidogrel.
Planned surgery within 12 months.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Primary outcome

MLD SB Diameter
Time frame: day 1
Optical coherence tomography (OCT) - a high resolution intravascular imaging technique to assess side branch size. Side branch diameter will be measured by QAngio OCT software from Medis. Three-Dimensional Quantitative Coronary Angiography (3D-QCA) Analysis of Bifurcation Lesions Before (PRE) and After (POST) Provisional Stenting. Main vessel minimal lumen diameter (MLD)

3 secondary outcomes

SB Angle
Time frame: day 1
SB Ostial Involvement
Time frame: day 1
Diameter Stenosis (DS)
Time frame: day 1

Results and safety

Results posted to the registry on 7 Jul 2016, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Provisional Stenting Strategy	30	30

Primary outcome: MLD SB Diameter

Time frame: day 1. Mean (Standard Error). Unit: mm

Measure	SB Ostium DS >50% n = 10	SB Ostium DS ≤50% n = 20
PRE	08. (0.1)	1.0 (0.1)
POST	2.3 (0.1)	2.2 (0.1)

3 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
SB Ostium DS >50%	0 of 0	0 of 0	Not reported
SB Ostium DS ≤50%	0 of 0	0 of 0	Not reported

Limitations and caveats (from the sponsor): Small number of cases. Results represent a hypothesis-generating pilot study rather than a definitive result.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 7 Jul 2016.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Results publication: PubMed 27029714Kini AS, Vengrenyuk Y, Pena J, Yoshimura T, Panwar SR, Motoyama S, Kezbor S, Hasan CM, Palkhiwala S, Kovacic JC, Moreno P, Baber U, Mehran R, Narula J, Sharma SK. Plaque morphology predictors of side branch occlusion after provisional stenting in coronary bifurcation lesion: Results of optical coherence tomography bifurcation study (ORBID). Catheter Cardiovasc Interv. 2017 Feb 1;89(2):259-268. doi: 10.1002/ccd.26524. Epub 2016 Mar 31.

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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.

Annapoorna Kini, MD principal investigator

Icahn School of Medicine at Mount Sinai

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, run by Icahn School of Medicine at Mount Sinai at 1 site in United States.

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 2 inclusion and 9 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: finished, as of the sponsor's last update on 7 Jul 2016. 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 United States. 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?

Yes. Results are posted in the registry (first posted 7 Jul 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

MLD SB Diameter (time frame: day 1). 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 NCT02364778, 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 7 Jul 2016.