Status:
COMPLETED
Scoreflex NC - Scoring PTCA Catheter
Lead Sponsor:
OrbusNeich
Collaborating Sponsors:
ClinLogix. LLC
Conditions:
Coronary Artery Disease
Coronary Disease
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
A prospective, open label, multi-center, single arm, observational study designed to evaluate the acute safety and device procedural success of the Scoreflex NC Scoring Percutaneous Transluminal Coron...
Eligibility Criteria
Inclusion
- Clinical Inclusion Criteria
- 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 that would interfere with the endpoints of this study.
- Subjects must have a single or double vessel coronary artery disease (CAD) and clinical evidence of ischemic heart disease, such as CAD, stable / unstable angina or silent ischemia.
- Angiographic Inclusion Criteria
- Subject must have de novo or restenotic lesion(s) in native coronary arteries, including in-stent restenosis suitable for percutaneous coronary intervention.
- A maximum of two lesions, including at least one target lesion, in up to two coronary arteries.
- Target lesion must have a reference vessel diameter (RVD) between 1.75 and 4.0 mm by visual estimation.
- Target lesion(s) must have a diameter stenosis of ≥70% by visual estimation and may include chronic total occlusions (CTO).
- The non-target lesion must be located in different coronary artery from the Target lesion.
- Treatment of non-target lesion, if any, must be completed prior to treatment of target lesion and must be deemed a clinical angiographic success as visually assessed by the physician.
- Clinical Exclusion Criteria:
- 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 STEMI or NSTEMI at index presentation or within 7 days of study screening.
- Subject with known pregnancy or is nursing. Women of child-bearing 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 7 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)
- Target lesion located within an arterial or saphenous vein graft or graft anastomosis
- Angiographic Exclusion Criteria
- More than two lesions requiring treatment.
- Target lesion longer than 30 mm by visual estimation.
- Extreme angulation (90º or greater) proximal to or within the target lesion.
- Previous percutaneous intervention of lesions in a target vessel (including side branches) conducted within 9 months before the study procedure and located within 10 mm from the current target lesion.
- Target lesion demonstrating severe dissection prior to planned deployment of the Scoreflex NC device
- Unprotected left main coronary artery disease. (Greater than 50% diameter stenosis)
- Coronary artery spasm of the target vessel in the absence of a significant stenosis.
- Target lesion with angiographic presence of probable or definite thrombus.
- 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
Exclusion
Key Trial Info
Start Date :
February 27 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 27 2019
Estimated Enrollment :
200 Patients enrolled
Trial Details
Trial ID
NCT03763747
Start Date
February 27 2019
End Date
December 27 2019
Last Update
August 11 2021
Active Locations (9)
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1
The Cardiac and Vascular Institute Research Foundation
Gainesville, Florida, United States, 32605
2
University of Miami
Miami, Florida, United States, 33136
3
Piedmont Heart Institute
Atlanta, Georgia, United States, 30309
4
Atlanta VA Healthcare System
Decatur, Georgia, United States, 30033