Coronary Artery DiseasePhase 3NCT01635881

Evaluation of Coronary Luminal Diameter Enlargement With Emerge™ 1.20 mm PTCA Dilatation Catheter

A Phase 3 study testing Emerge™ 1.20 mm PTCA Dilatation Catheter in people with Coronary Artery Disease, run by Boston Scientific Corporation 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

To evaluate the acute safety and device procedural success of the Emerge 1.20 mm PTCA dilatation catheter when used as a pre-dilatation device in the stenotic portion of coronary arteries or bypass grafts. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Coronary Artery Disease
What is being tested?: Emerge™ 1.20 mm PTCA Dilatation Catheter
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 60 participants
Where: 1 siteUnited States
Study dates: Jul 2012to Dec 2012
Phase: Phase 3
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 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

None listed.

Who cannot join

Subject with a known hypersensitivity or contraindication to Aspirin, Heparin, Bivalirudin, anti-platelet medications, or sensitivity to contrast media which cannot be adequately pre-medicated.
Subject with known diagnosis of an acute myocardial infarction (AMI) within 72 hours prior to index procedure.
Subject with known pregnancy or is nursing. Women of childbearing potential should have a documented negative pregnancy test within 7 days before index procedure.
Planned or actual target lesion treatment with an unapproved device, atherectomy, laser, cutting balloon or thrombectomy during the index procedure.
A serum creatinine level > 2.0 mg/dl within seven days prior to index procedure.
Cerebrovascular accident (CVA) within the past 6 months.

Show all 21Show fewer

Active peptic ulcer or active gastrointestinal (GI) bleeding within the past 6 months.
Subject has a known left ventricular ejection fraction (LVEF) <30% (LVEF may be obtained at the time of the index procedure if the value is unknown, if necessary).
Angiographic Exclusion Criteria
More than two lesions requiring treatment.
Unprotected left main coronary artery disease.
Coronary artery spasm of the target vessel in the absence of a significant stenosis.
Target lesion with angiographic presence of probable or definite thrombus.
Untreated lesions with >50% diameter stenosis remaining in any coronary artery.
Target lesion involves a bifurcation requiring treatment with more than one stent or pre-dilatation of a side branch >2.0 mm in diameter.
Non-target lesion to be treated during the index procedure meets any of the following criteria:
Located within a bypass graft (venous or arterial)
Left main location
Chronic total occlusion
Involves a bifurcation (e.g., bifurcations requiring treatment with more than 1 stent)
Treatment not deemed a clinical angiographic success

Trial locations and contacts

1 site in 1 country.

United States1 site

Piedmont Heart Institute
Atlanta, Georgia, 30309

Other trials in United States

About this study

Official title: EMERGE: Evaluation of Coronary Luminal Diameter Enlargement With Emerge™ 1.20 mm Percutaneous Transluminal Coronary Angioplasty (PTCA) Dilatation Catheter

Conditions: Coronary Artery Disease
Being tested: Emerge™ 1.20 mm PTCA Dilatation Catheter
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.

Emerge™ 1.20 mm PTCA Dilatation CatheterDevice
The Emerge 1.20 mm device is the next-generation Boston Scientific PTCA dilatation catheter. It is a sterile, single-use, intravascular medical device used to improve lumen diameter.
The catheter consists of a shaft with a balloon near the distal tip. The balloon is designed to provide an inflatable segment of known diameter and length at recommended pressures.

Study groups in NCT01635881
Study group	Role	What they receive
Emerge	Experimental	Single arm with investigational Emerge™ 1.20 mm PTCA Dilatation Catheter Receives: Device: Emerge™ 1.20 mm PTCA Dilatation Catheter

What is being measured

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

Device Procedural Success
Device procedural success consisting of the following:
1. Successful delivery, inflation, deflation and withdrawal of the study balloon.
2. No evidence of vessel perforation, flow limiting dissection (grade C or higher) or reduction in TIMI flow from baseline related to the study balloon.
3. Final TIMI flow grade of 3 at the conclusion of the percutaneous coronary intervention procedure
Measured: Peri-procedural

Secondary outcomes (1)

In-hospital Major Adverse Cardiac Events (MACE)
In-hospital MACE:
1. All death (cardiac and non-cardiac)
2. Myocardial infarction (MI)
3. Target Vessel Revascularization (TVR)
4. In-hospital Stent Thrombosis (ST) within the target vessel
5. Clinically significant arrhythmias (requiring intervention)
Measured: Participants will be followed for the duration of hospital stay (an expected average of 24 hours)

Timeline

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

Jul 2012Dec 2012

First posted10 Jul 2012 (estimated)
Study startJul 2012
Primary completionDec 2012
Study completionDec 2012

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.
Other trials for Coronary Artery DiseaseStudies of the same condition, open and under way.
More trials run by Boston Scientific CorporationThe 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: Interventional
Phase: Phase 3
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 60 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01635881
Sponsor's protocol ID: S2228
Status last verified: Oct 2013
First submitted: 25 May 2012
Last updated: 6 Nov 2013
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

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 6 Nov 2013. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: EMERGE: Evaluation of Coronary Luminal Diameter Enlargement With Emerge™ 1.20 mm Percutaneous Transluminal Coronary Angioplasty (PTCA) Dilatation Catheter
ClinicalTrials.gov ID: NCT01635881
Acronym / sponsor ID: S2228
Conditions: Coronary Artery Disease
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 60 participants (actual)
Lead sponsor: Boston Scientific CorporationIndustry (pharma, biotech, devices)
Study start: Jul 2012
Primary completion: Dec 2012 (actual)
Study completion: Dec 2012 (actual)
First posted: 10 Jul 2012 (estimated)
Results: Posted 6 Nov 2013

Clinical summary

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

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Emerge	Experimental	Device: Emerge™ 1.20 mm PTCA Dilatation CatheterSingle arm with investigational Emerge™ 1.20 mm PTCA Dilatation Catheter

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (0 listed)

Key exclusion criteria (21 listed)

Subject with a known hypersensitivity or contraindication to Aspirin, Heparin, Bivalirudin, anti-platelet medications, or sensitivity to contrast media which cannot be adequately pre-medicated.
Subject with known diagnosis of an acute myocardial infarction (AMI) within 72 hours prior to index procedure.
Subject with known pregnancy or is nursing. Women of childbearing potential should have a documented negative pregnancy test within 7 days before index procedure.
Planned or actual target lesion treatment with an unapproved device, atherectomy, laser, cutting balloon or thrombectomy during the index procedure.
A serum creatinine level > 2.0 mg/dl within seven days prior to index procedure.

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
Emerge™ 1.20 mm PTCA Dilatation CatheterThe Emerge 1.20 mm device is the next-generation Boston Scientific PTCA dilatation catheter. It is a sterile, single-use, intravascular medical device used to improve lumen diameter. The catheter consists of a shaft with a balloon near the distal tip. The balloon is designed to provide an inflatable segment of known diameter and length at recommended pressures.	Device	Emerge

Primary outcome

Device Procedural Success
Time frame: Peri-procedural
Device procedural success consisting of the following: 1. Successful delivery, inflation, deflation and withdrawal of the study balloon. 2. No evidence of vessel perforation, flow limiting dissection (grade C or higher) or reduction in TIMI flow from baseline related to the study balloon. 3. Final TIMI flow grade of 3 at the conclusion of the percutaneous coronary intervention procedure

1 secondary outcome

In-hospital Major Adverse Cardiac Events (MACE)
Time frame: Participants will be followed for the duration of hospital stay (an expected average of 24 hours)

Results and safety

Results posted to the registry on 6 Nov 2013, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Emerge	60	60

Primary outcome: Device Procedural Success

Time frame: Peri-procedural. Number (95% Confidence Interval). Unit: percentage of participants

Measure	Emerge n = 60
Value	98.3 (91.1 to 100.0)

Population analysed: Analysis population consists of intent-to-treat subject population.

1 secondary outcome is reported in the full results.

Adverse events

Time frame: Serious and non-serious adverse events were collected from the point of subject enrollment through study completion at hospital discharge.. Other adverse events reported at 1.0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Emerge	2 of 60 (3.3%)	6 of 60 (10%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 6 Nov 2013.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

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The OCTOBER Trial - European Trial on Optical Coherence Tomography Optimized Bifurcation Event Reduction (OCTOBER)
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RecruitingEarly Phase 1
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Recruiting
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RecruitingObservational study
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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.

David E Kandzari, MD principal investigator

Director, Interventional Cardiology, Chief Scientific Officer, Piedmont Heart Institute

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Emerge™ 1.20 mm PTCA Dilatation Catheter in people with Coronary Artery Disease, run by Boston Scientific Corporation 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 0 inclusion and 21 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 6 Nov 2013. 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.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 6 Nov 2013). 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?

Device Procedural Success (time frame: Peri-procedural). 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 NCT01635881.

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 6 Nov 2013; AzTrials last refreshed its copy on 8 Nov 2026.