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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Boston Scientific Corporation
ClinicalTrials.gov Identifier:
NCT01635881
First received: May 25, 2012
Last updated: October 14, 2013
Last verified: October 2013
  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.


Condition Intervention Phase
Coronary Artery Disease
Device: Emerge™ 1.20 mm PTCA Dilatation Catheter
Phase 3

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: EMERGE: Evaluation of Coronary Luminal Diameter Enlargement With Emerge™ 1.20 mm Percutaneous Transluminal Coronary Angioplasty (PTCA) Dilatation Catheter

Resource links provided by NLM:


Further study details as provided by Boston Scientific Corporation:

Primary Outcome Measures:
  • Device Procedural Success [ Time Frame: Peri-procedural ] [ Designated as safety issue: Yes ]

    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


Secondary Outcome Measures:
  • 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) ] [ Designated as safety issue: Yes ]

    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)


Enrollment: 60
Study Start Date: July 2012
Study Completion Date: December 2012
Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Emerge
Single arm with investigational Emerge™ 1.20 mm PTCA Dilatation Catheter
Device: Emerge™ 1.20 mm PTCA Dilatation Catheter

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.


  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01635881

Locations
United States, Georgia
Piedmont Heart Institute
Atlanta, Georgia, United States, 30309
Sponsors and Collaborators
Boston Scientific Corporation
Investigators
Principal Investigator: David E Kandzari, MD Director, Interventional Cardiology, Chief Scientific Officer, Piedmont Heart Institute
  More Information

No publications provided

Responsible Party: Boston Scientific Corporation
ClinicalTrials.gov Identifier: NCT01635881     History of Changes
Other Study ID Numbers: S2228
Study First Received: May 25, 2012
Results First Received: August 9, 2013
Last Updated: October 14, 2013
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Hypertrophy
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Pathological Conditions, Anatomical

ClinicalTrials.gov processed this record on July 31, 2014