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

May 25, 2012
October 14, 2013
July 2012
December 2012   (final data collection date for primary outcome measure)
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
Device Procedural Success [ Time Frame: Hospital Discharge ] [ 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 PCI procedure
Complete list of historical versions of study NCT01635881 on ClinicalTrials.gov Archive Site
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)
  • 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) ] [ Designated as safety issue: Yes ]

    In-hospital Major Adverse Cardiac Events (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)
  • Peri-Procedural Endpoint [ Time Frame: Participants will be followed for the duration of hospital stay (an expected average of 24 hours) ] [ Designated as safety issue: Yes ]
    1. Balloon rupture
    2. Improvement in Minimum Lumen Diameter (MLD) following predilatation with Emerge 1.20 mm PTCA dilatation catheter (measured by QCA)
Not Provided
Not Provided
 
Evaluation of Coronary Luminal Diameter Enlargement With Emerge™ 1.20 mm PTCA Dilatation Catheter
EMERGE: Evaluation of Coronary Luminal Diameter Enlargement With Emerge™ 1.20 mm Percutaneous Transluminal Coronary Angioplasty (PTCA) Dilatation Catheter

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.

Not Provided
Interventional
Phase 3
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Coronary Artery Disease
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.

Experimental: Emerge
Single arm with investigational Emerge™ 1.20 mm PTCA Dilatation Catheter
Intervention: Device: Emerge™ 1.20 mm PTCA Dilatation Catheter
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
60
December 2012
December 2012   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01635881
S2228
No
Boston Scientific Corporation
Boston Scientific Corporation
Not Provided
Principal Investigator: David E Kandzari, MD Director, Interventional Cardiology, Chief Scientific Officer, Piedmont Heart Institute
Boston Scientific Corporation
October 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP