Scoreflex NC - Scoring PTCA Catheter

Not Applicable

Completed

• Conditions: Coronary Disease; Cardiovascular Diseases; Coronary Artery Disease; Myocardial Ischemia; Heart Diseases; Arteriosclerosis
• Interventions: Device: Scoreflex NC Scoring PTCA catheter

• Registration Number: NCT03763747
• Lead Sponsor: OrbusNeich

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 Coronary Angioplasty (PTCA) catheters in subjects with stenotic coronary arteries during percutaneous coronary intervention.

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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2018-12-03
• Study First Submitted QC: 2018-12-03
• Study First Posted: 2018-12-04
• Study Start: 2019-02-27
• Primary Completion: 2019-12-27
• Study Completion: 2019-12-27
• Results First Submitted: 2021-05-04
• Status Verified: 2021-07
• Results First Submitted QC: 2021-07-19
• Last Update Submitted: 2021-07-19
• Results First Posted: 2021-08-11
• Last Update Posted: 2021-08-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

Not provided

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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 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

   Angiographic Exclusion Criteria

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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Scoreflex NC Scoring PTCA Catheter	Scoreflex NC Scoring PTCA catheter	Single arm with investigational Scoreflex NC Scoring PTCA catheters

Primary Outcome Measures

Name	Time	Method
Number of Participants With Device Procedural Success	Peri-procedural (at Day 0)	Device procedural success consisting of the following: * Successful delivery, inflation, deflation, and withdrawal of the study balloon; * No evidence of vessel perforation, flow limiting dissection (grade C or higher) or reduction in Thrombolysis In Myocardial Infarction (TIMI) flow from baseline as related to the Scoreflex NC study balloon; * Final TIMI flow grade of 3 at the conclusion of the percutaneous coronary intervention (PCI) procedure

Secondary Outcome Measures

Name	Time	Method
Number of Participants With In-hospital Stent Thrombosis (ST) Within the Target Vessel	Endpoint will be measured through hospital discharge (expected to be within 24 hours)	In-hospital stent thrombosis (ST) within the Target Vessel
Number of Participants With Clinically Significant Arrhythmias (Requiring Intervention)	Endpoint will be measured through hospital discharge (expected to be within 24 hours)	Clinically Significant Arrhythmias (Requiring Intervention)
Number of Participants With Angiographic Procedural Success	Peri-procedural (at Day 0)	Angiographic Procedural Success defined as Final diameter stenosis ≤ 50% in at least one of the Scoreflex NC attempted lesions following completion of the interventional procedure, including adjunctive stenting
Number of Participants With In-hospital Major Adverse Cardiac Events (MACE)	Endpoints will be measured through hospital discharge (expected to be within 24 hours)	In-hospital Major Adverse Cardiac Events (MACE), a composite of: * All death (cardiac and non-cardiac); * Myocardial infarction (MI); * Target Lesion Revascularization (TLR), clinically indicated
Number of Scoreflex NC Scoring Catheters That Had Occurrence of Balloon Rupture	Peri-procedural	Occurrence of Scoreflex NC Study Balloon rupture
Number of Participants That Had Improvement in Minimum Lumen Diameter (MLD) Following Use of Scoreflex NC Catheter (Measured by Quantitative Coronary Angiography (QCA))	Peri-procedural	Improvement in Minimum Lumen Diameter (MLD) following use of Scoreflex NC catheter (measured by QCA).; Improvement in MLD is defined as MLD post use of Scoreflex as greater than MLD from baseline.

Trial Locations

Locations (9)

The Cardiac and Vascular Institute Research Foundation; 🇺🇸 Gainesville, Florida, United States

Piedmont Heart Institute; 🇺🇸 Atlanta, Georgia, United States

Cardiology Associates Research, LLC; 🇺🇸 Tupelo, Mississippi, United States

Deborah Heart and Lung Center; 🇺🇸 Browns Mills, New Jersey, United States

Atlanta VA Healthcare System; 🇺🇸 Decatur, Georgia, United States

CentraCare Heart and Vascular Center; 🇺🇸 Saint Cloud, Minnesota, United States

Delmarva Heart Research Foundation Inc./Peninsula Regional Medical Center; 🇺🇸 Salisbury, Maryland, United States

University of Miami; 🇺🇸 Miami, Florida, United States

The Lindner Research Center/The Christ Hospital Heart and Vascular; 🇺🇸 Cincinnati, Ohio, United States