Study Results
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View full resultsBasic Information
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COMPLETED
NA
200 participants
INTERVENTIONAL
2019-02-27
2019-12-27
Brief Summary
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Two-hundred (200) subjects will be treated at up to 15 U.S. sites with the Scoreflex NC Scoring PTCA catheter during their index procedure. All subjects will be screened according to the protocol inclusion and exclusion criteria and will be followed through hospital discharge.
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Scoreflex NC Scoring PTCA Catheter
Single arm with investigational Scoreflex NC Scoring PTCA catheters
Scoreflex NC Scoring PTCA catheter
To dilate coronary arteries during the subject's index procedure with Scoreflex NC Scoring PTCA catheters
Interventions
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Scoreflex NC Scoring PTCA catheter
To dilate coronary arteries during the subject's index procedure with Scoreflex NC Scoring PTCA catheters
Eligibility Criteria
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Inclusion Criteria
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 that would interfere with the endpoints of this study.
4. 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.
5. Subject must have de novo or restenotic lesion(s) in native coronary arteries, including in-stent restenosis suitable for percutaneous coronary intervention.
6. A maximum of two lesions, including at least one target lesion, in up to two coronary arteries.
7. Target lesion must have a reference vessel diameter (RVD) between 1.75 and 4.0 mm by visual estimation.
8. Target lesion(s) must have a diameter stenosis of ≥70% by visual estimation and may include chronic total occlusions (CTO).
9. The non-target lesion must be located in different coronary artery from the Target lesion.
10. 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.
Exclusion Criteria
2. Subject with known diagnosis of STEMI or NSTEMI at index presentation or within 7 days of study screening.
3. 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.
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 7 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)
9. Target lesion located within an arterial or saphenous vein graft or graft anastomosis
10. More than two lesions requiring treatment.
11. Target lesion longer than 30 mm by visual estimation.
12. Extreme angulation (90º or greater) proximal to or within the target lesion.
13. 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.
14. Target lesion demonstrating severe dissection prior to planned deployment of the Scoreflex NC device
15. Unprotected left main coronary artery disease. (Greater than 50% diameter stenosis)
16. Coronary artery spasm of the target vessel in the absence of a significant stenosis.
17. Target lesion with angiographic presence of probable or definite thrombus.
18. Target lesion involves a bifurcation requiring treatment with more than one stent or pre-dilatation of a side branch \>2.0 mm in diameter.
19. 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
18 Years
ALL
No
Sponsors
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ClinLogix. LLC
INDUSTRY
OrbusNeich
INDUSTRY
Responsible Party
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Principal Investigators
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David Kandzari, MD
Role: PRINCIPAL_INVESTIGATOR
Piedmont Heart Institute
Locations
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The Cardiac and Vascular Institute Research Foundation
Gainesville, Florida, United States
University of Miami
Miami, Florida, United States
Piedmont Heart Institute
Atlanta, Georgia, United States
Atlanta VA Healthcare System
Decatur, Georgia, United States
Delmarva Heart Research Foundation Inc./Peninsula Regional Medical Center
Salisbury, Maryland, United States
CentraCare Heart and Vascular Center
Saint Cloud, Minnesota, United States
Cardiology Associates Research, LLC
Tupelo, Mississippi, United States
Deborah Heart and Lung Center
Browns Mills, New Jersey, United States
The Lindner Research Center/The Christ Hospital Heart and Vascular
Cincinnati, Ohio, United States
Countries
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References
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Kandzari D, Hearne S, Kumar G, Sachdeva R, Adams G, Blossom B, Dahle T, Sanghvi K, Cohen MG, Imperi G, Riley R, Almonacid AP. Procedural Effectiveness With a Focused Force Scoring Angioplasty Catheter: Procedural and Clinical Outcomes From the Scoreflex NC Trial. Cardiovasc Revasc Med. 2022 Feb;35:85-90. doi: 10.1016/j.carrev.2021.03.013. Epub 2021 Mar 20.
Louvard Y, Medina A. Definitions and classifications of bifurcation lesions and treatment. EuroIntervention. 2015;11 Suppl V:V23-6. doi: 10.4244/EIJV11SVA5.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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VP-0730
Identifier Type: -
Identifier Source: org_study_id
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