Evaluation of Coronary Luminal Diameter Enlargement With Emerge™ 1.20 mm PTCA Dilatation Catheter
Condition: Coronary Artery Disease
MeSH terms: Coronary Artery Disease
Intervention: Emerge™ 1.20 mm PTCA Dilatation Catheter
Intervention 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.
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 60.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

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.
    

Eligibility 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