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

Completed · Phase 3

Conditions studied: Coronary Artery Disease

In brief

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.

Key facts

Study ID

NCT01635881

Run by

Boston Scientific Corporation

People needed

60

Starts

2012-07-01

Expected to finish

2012-12-01

Last updated by the study team

2013-11-06

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

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).
• 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

Where it is running

• Piedmont Heart Institute — Atlanta, Georgia, United States

Full record on ClinicalTrials.gov

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