Sapphire 3 CTO Study

NCT06358508 | Completed FDA Device

• 1 other identifier: VP-0786
• Study Type: interventional
• Target: 170
• Locations: 2 countries
• Sites: 14

Brief Summary

A prospective, open label, multi-center, single arm, observational study designed to evaluate the acute safety and device performance of the Sapphire 3 0.85, 1.0 and 1.25mm diameter coronary dilatation catheter in predilatation of Chronic Total Occlusion (CTO) lesions during percutaneous coronary intervention. One hundred seventy (170) subjects will be enrolled with a target of one hundred fifty-three (153) evaluable subjects by the angiographic core laboratory at up to 15 clinical sites with the Sapphire 3 0.85, 1.0 and 1.25mm diameter PTCA dilatation catheter to pre-dilate CTO lesions in coronary arteries during their index procedure. All subjects will be screened according to the protocol inclusion and exclusion criteria and will be followed through study completion, which is defined as 24-hours post-procedure or hospital discharge, whichever comes first.

Conditions

Coronary Disease; Myocardial Ischemia; Heart Diseases; Arteriosclerosis; Chronic Total Occlusion; Chronic Total Occlusion of Coronary Artery; Coronary Artery Disease; Cardiovascular Diseases

Keywords

Coronary Artery Disease; Coronary Disease; Myocardial Ischemia; Heart Diseases; Arteriosclerosis; Cardiovascular Diseases; Chronic Total Occlusion; Chronic Total Occlusion of Coronary Artery

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 and after the guidewire has successfully crossed the CTO lesion into the true lumen of the vessel * No evidence of vessel perforation or dissections (Grade C or higher) related to the study balloon * Final TIMI flow grade of II or III at the conclusion of the PCI procedure

  24 hours post-procedure or hospital discharge, whichever comes first

Secondary Outcomes (9)

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

  24 hours post-procedure or hospital discharge, whichever comes first

• Number of Deaths (Cardiac and Non-Cardiac)

  24 hours post-procedure or hospital discharge, whichever comes first

• Number of Participants With Myocardial Infarctions (MI)

  24 hours post-procedure or hospital discharge, whichever comes first

• Number of Participants With Target Lesion Revascularization (TLR)

  24 hours post-procedure or hospital discharge, whichever comes first

• Number of Participants With In-hospital stent thrombosis (ST) Within the Target Vessel

  24 hours post-procedure or hospital discharge, whichever comes first

Study Arms (1)

Sapphire 3 Coronary Dilatation Catheter

EXPERIMENTAL

Single arm with investigational Sapphire 3 Coronary Dilatation Catheters

Device: Sapphire 3 Coronary Dilatation Catheter

Interventions

Sapphire 3 Coronary Dilatation Catheter DEVICE

To pre-dilate Chronic Total Occlusion (CTO) lesions in coronary arteries during the subject's index procedure with Sapphire 3 0.85mm, 1.0mm, and 1.25mm diameter Coronary Dilatation Catheters.

Sapphire 3 Coronary Dilatation 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 and clinical evidence of ischemic heart disease, such as stable / unstable angina or silent ischemia attributed to the CTO target vessel and is scheduled for clinically indicated percutaneous revascularization with planned stent placement during this index procedure.
• Subject must have at least one de novo or restenotic lesion in native coronary arteries with Thrombolysis In Myocardial Infarction (TIMI) flow grade of 0 or 1 and is estimated to be at least 3 months in duration by clinical, angiographic, or electrocardiographic criteria.
• A maximum of two lesions, including at least one target lesion, in up to two coronary arteries.
• Treatment of non-target lesion, if any, must be completed prior to treatment of target lesion and must be deemed a clinical angiographic success by visual assessment.
• The Target lesion is intended for stent placement during this index procedure.

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.
• Evidence of acute myocardial infarction (MI) within 72 hours prior to the intended treatment defined as CK-MB or troponin greater than 1X the upper limit of normal (ULN).
• 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 prior to the use of the Study Device with an unapproved device, atherectomy, laser, cutting balloon or thrombectomy during the index procedure.
• A serum creatinine level \> 2.0 mg/dl within seven 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).
• More than two lesions requiring treatment.
• 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 of TIMI thrombus grade 3 or 4.
• By visual estimation, target lesion involves a bifurcation requiring treatment with more than one stent or pre-dilatation of a side branch \>2.25 mm in diameter.
• Previous coronary interventional procedure of any kind within the 30 days prior to the procedure in the target vessel.
• Target vessel with a patent bypass graft from prior coronary bypass surgery.

Sponsors & Collaborators

• Avania: collaborator
• OrbusNeich: lead

Study Sites (14)

Stanford Health Care

Stanford, California, 94305, United States

Location

Torrance Memorial Medical Center

Torrance, California, 90505, United States

Location

Emory University Hospital Midtown

Atlanta, Georgia, 30308, United States

Location

Piedmont Heart Institute

Atlanta, Georgia, 30309, United States

Location

Emory University Hospital

Atlanta, Georgia, 30322, United States

Location

Emory St. Joseph's Hospital

Atlanta, Georgia, 30342, United States

Location

Atlanta VA Health Care System

Decatur, Georgia, 30033, United States

Location

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

Brigham and Women's Hospital Heart and Vascular Center

Boston, Massachusetts, 02115, United States

Location

Henry Ford Health System

Detroit, Michigan, 48202, United States

Location

Minneapolis Heart Institute Foundation

Minneapolis, Minnesota, 55407, United States

Location

University of Washington

Seattle, Washington, 98195, United States

Location

Hospital Universitari de Bellvitge

Barcelona, 08907, Spain

Location

Hospital Clinico Universitario de Valladolid

Valladolid, 47003, Spain

Location

MeSH Terms

Conditions

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

Condition Hierarchy (Ancestors)

Arterial Occlusive Diseases; Vascular Diseases

Study Officials

• David Kandzari, MD

  Piedmont Heart Institute

  PRINCIPAL INVESTIGATOR

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: April 5, 2024
• First Posted: April 10, 2024
• Study Start: November 6, 2024
• Primary Completion: October 21, 2025
• Study Completion: October 21, 2025
• Last Updated: January 12, 2026

Record last verified: 2026-01

Locations

ES (2); US (12)