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

NCT01635881 | Completed Phase 3 Results

• 1 other identifier: S2228
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Coronary Artery Disease

Outcome Measures

Primary Outcomes (1)

• 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

  Peri-procedural

Secondary Outcomes (1)

• In-hospital Major Adverse Cardiac Events (MACE)

  Participants will be followed for the duration of hospital stay (an expected average of 24 hours)

Study Arms (1)

Emerge

EXPERIMENTAL

Single arm with investigational Emerge™ 1.20 mm PTCA Dilatation Catheter

Device: Emerge™ 1.20 mm PTCA Dilatation Catheter

Interventions

Emerge™ 1.20 mm PTCA Dilatation Catheter DEVICE

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.

Emerge

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subject is ≥ 18 years of age.
• Subject or a legally authorized representative must provide written informed consent prior to any study related procedures.
• Subject must agree not to participate in any other clinical study during hospitalization for the index procedure.
• 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.
• 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.
• A maximum of two lesions, including at least one target lesion, in up to two coronary arteries.
• Target and non-target lesions must be located in different coronary arteries or bypass grafts.
• Target lesion(s) must have a diameter stenosis of ≥70% by visual estimation and may include chronic total occlusions (CTO)
• Treatment of non-target lesion, if any, must be completed prior to treatment of target lesion and must be deemed a clinical angiographic success.

You may not qualify if:

• 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.
• 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).
• 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:

Sponsors & Collaborators

• Boston Scientific Corporation: lead

Study Sites (1)

Piedmont Heart Institute

Atlanta, Georgia, 30309, United States

Location

MeSH Terms

Conditions

Coronary Artery Disease

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Results Point of Contact

• Title: Andrey Nersesov, Clinical Trial Manager
• Organization: Boston Scientific

Andrey.Nersesov@bsci.com

1-508-683-4988

Study Officials

• David E Kandzari, MD

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

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 25, 2012
• First Posted: July 10, 2012
• Study Start: July 1, 2012
• Primary Completion: December 1, 2012
• Study Completion: December 1, 2012
• Last Updated: November 6, 2013
• Results First Posted: November 6, 2013

Record last verified: 2013-10

Locations

US (1)