Scoreflex NC - Scoring PTCA Catheter

NCT03763747 | Completed Results FDA Device

• 1 other identifier: VP-0730
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 9

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.

Conditions

Coronary Artery Disease; Coronary Disease; Myocardial Ischemia; Heart Diseases; Arteriosclerosis; Cardiovascular Diseases

Keywords

Coronary Artery Disease; Coronary Disease; Myocardial Ischemia; Heart Diseases; Arteriosclerosis; Cardiovascular Diseases

Outcome Measures

Primary Outcomes (1)

• Number of Participants With Device Procedural Success

  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

  Peri-procedural (at Day 0)

Secondary Outcomes (6)

• Number of Participants With Angiographic Procedural Success

  Peri-procedural (at Day 0)

• Number of Participants With In-hospital Major Adverse Cardiac Events (MACE)

  Endpoints will be measured through hospital discharge (expected to be within 24 hours)

• 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)

• Number of Participants With Clinically Significant Arrhythmias (Requiring Intervention)

  Endpoint will be measured through hospital discharge (expected to be within 24 hours)

• Number of Scoreflex NC Scoring Catheters That Had Occurrence of Balloon Rupture

  Peri-procedural

Study Arms (1)

Scoreflex NC Scoring PTCA Catheter

EXPERIMENTAL

Single arm with investigational Scoreflex NC Scoring PTCA catheters

Device: Scoreflex NC Scoring PTCA catheter

Interventions

Scoreflex NC Scoring PTCA catheter DEVICE

To dilate coronary arteries during the subject's index procedure with Scoreflex NC Scoring PTCA catheters

Scoreflex NC Scoring PTCA Catheter

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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.

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 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
• 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)

Sponsors & Collaborators

• OrbusNeich: lead
• ClinLogix. LLC: collaborator

Study Sites (9)

The Cardiac and Vascular Institute Research Foundation

Gainesville, Florida, 32605, United States

Location

University of Miami

Miami, Florida, 33136, United States

Location

Piedmont Heart Institute

Atlanta, Georgia, 30309, United States

Location

Atlanta VA Healthcare System

Decatur, Georgia, 30033, United States

Location

Delmarva Heart Research Foundation Inc./Peninsula Regional Medical Center

Salisbury, Maryland, 21804, United States

Location

CentraCare Heart and Vascular Center

Saint Cloud, Minnesota, 56303, United States

Location

Cardiology Associates Research, LLC

Tupelo, Mississippi, 38801, United States

Location

Deborah Heart and Lung Center

Browns Mills, New Jersey, 08015, United States

Location

The Lindner Research Center/The Christ Hospital Heart and Vascular

Cincinnati, Ohio, 45219, United States

Location

Related Publications (2)

• 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.

  PMID: 33781677 RESULT

• Louvard Y, Medina A. Definitions and classifications of bifurcation lesions and treatment. EuroIntervention. 2015;11 Suppl V:V23-6. doi: 10.4244/EIJV11SVA5.

  PMID: 25983165 RESULT

MeSH Terms

Conditions

Coronary Artery Disease; Coronary Disease; Myocardial Ischemia; Heart Diseases; Arteriosclerosis; Cardiovascular Diseases

Condition Hierarchy (Ancestors)

Arterial Occlusive Diseases; Vascular Diseases

Results Point of Contact

• Title: Stephen M. Rowland, PhD - Vice-President, Research and Development
• Organization: OrbusNeich

srowland@orbusneich.com

954-730-0711

Study Officials

• David Kandzari, MD

  Piedmont Heart Institute

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 3, 2018
• First Posted: December 4, 2018
• Study Start: February 27, 2019
• Primary Completion: December 27, 2019
• Study Completion: December 27, 2019
• Last Updated: August 11, 2021
• Results First Posted: August 11, 2021

Record last verified: 2021-07

Locations

US (9)