Atlanta, Georgia 30309

  • Coronary Artery Disease

Purpose:

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.


Criteria:

Clinical Inclusion Criteria: 1. Subject is ≥ 18 years of age. 2. Subject or a legally authorized representative must provide written informed consent prior to any study related procedures. 3. Subject must agree not to participate in any other clinical study during hospitalization for the index procedure. 4. Subjects must have a single or double vessel coronary artery disease and clinical evidence of ischemic heart disease, such as stable / unstable angina or silent ischemia. Angiographic Inclusion Criteria: 1. Subject must have de novo or restenotic lesion(s) in native coronary arteries or bypass grafts that are suitable for percutaneous coronary intervention. An embolic protection device must be used in all Saphenous venous grafts (SVG) interventions performed during the index procedure. 2. A maximum of two lesions, including at least one target lesion, in up to two coronary arteries. 3. Target and non-target lesions must be located in different coronary arteries or bypass grafts. 4. Target lesion(s) must have a diameter stenosis of ≥70% by visual estimation and may include chronic total occlusions (CTO) 5. Treatment of non-target lesion, if any, must be completed prior to treatment of target lesion and must be deemed a clinical angiographic success. Exclusion Criteria: 1. 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. 2. Subject with known diagnosis of an acute myocardial infarction (AMI) within 72 hours prior to index procedure. 3. Subject with known pregnancy or is nursing. Women of childbearing potential should have a documented negative pregnancy test within 7 days before index procedure. 4. Planned or actual target lesion treatment with an unapproved device, atherectomy, laser, cutting balloon or thrombectomy during the index procedure. 5. A serum creatinine level > 2.0 mg/dl within seven days prior to index procedure. 6. Cerebrovascular accident (CVA) within the past 6 months. 7. Active peptic ulcer or active gastrointestinal (GI) bleeding within the past 6 months. 8. 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 1. More than two lesions requiring treatment. 2. Unprotected left main coronary artery disease. 3. Coronary artery spasm of the target vessel in the absence of a significant stenosis. 4. Target lesion with angiographic presence of probable or definite thrombus. 5. Untreated lesions with >50% diameter stenosis remaining in any coronary artery. 6. Target lesion involves a bifurcation requiring treatment with more than one stent or pre-dilatation of a side branch >2.0 mm in diameter. 7. Non-target lesion to be treated during the index procedure meets any of the following criteria: 1. Located within a bypass graft (venous or arterial) 2. Left main location 3. Chronic total occlusion 4. Involves a bifurcation (e.g., bifurcations requiring treatment with more than 1 stent) 5. Treatment not deemed a clinical angiographic success


Study is Available At:


Original ID:

S2228


NCT ID:

NCT01635881


Secondary ID:


Study Acronym:


Brief Title:

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


Official Title:

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


Overall Status:

Completed


Study Phase:

Phase 3


Genders:

Both


Minimum Age:

18 Years


Maximum Age:

N/A


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

Boston Scientific Corporation


Oversight Authority:

United States: Food and Drug Administration


Reasons Why Stopped:


Study Type:

Interventional


Study Design:

Endpoint Classification: Safety/Efficacy Study, I


Number of Arms:

1


Number of Groups:

0


Total Enrollment:

60


Enrollment Type:

Actual


Overall Contact Information

Official Name:David E Kandzari, MD
Principal Investigator
Director, Interventional Cardiology, Chief Scientific Officer, Piedmont Heart Institute

Study Dates

Start Date:July 2012
Completion Date:January 2013
Completion Type:Actual
Primary Completion Date:January 2013
Primary Completion Type:Actual
Verification Date:February 2013
Last Changed Date:February 11, 2013
First Received Date:May 25, 2012

Study Outcomes

Outcome Type:Primary Outcome
Measure:Device Procedural Success
Time Frame:Hospital Discharge
Safety Issues:True
Description:Device procedural success consisting of the following: Successful delivery, inflation, deflation and withdrawal of the study balloon. No evidence of vessel perforation, flow limiting dissection (grade C or higher) or reduction in TIMI flow from baseline
Outcome Type:Secondary Outcome
Measure:Safety EndPoints collected for all study patients through hospital discharge
Time Frame:Participants will be followed for the duration of hospital stay (an expected average of 24 hours)
Safety Issues:True
Description:In-hospital Major Adverse Cardiac Events (MACE) All death (cardiac and non-cardiac) Myocardial infarction (MI) Target Vessel Revascularization (TVR) In-hospital Stent Thrombosis (ST) within the target vessel Clinically significant arrhythmias (requir
Outcome Type:Secondary Outcome
Measure:Peri-Procedural Endpoint
Time Frame:Participants will be followed for the duration of hospital stay (an expected average of 24 hours)
Safety Issues:True
Description:Balloon rupture Improvement in Minimum Lumen Diameter (MLD) following predilatation with Emerge 1.20 mm PTCA dilatation catheter (measured by QCA)

Study Interventions

Intervention Type:Device
Name:Emerge™ 1.20 mm PTCA Dilatation Catheter
Description: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.
Arm Name:Emerge

Study Arms

Study Arm Type:Experimental
Arm Name:Emerge
Description:Single arm with investigational Emerge™ 1.20 mm PTCA Dilatation Catheter

Study Agencies

Agency Class:Industry
Agency Type:Lead Sponsor
Agency Name:Boston Scientific Corporation

Sample and Retention Information

There are no available Sample and Retention Information

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: August 01, 2021

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