Sapphire II PRO US Clinical Study

NCT03052530 | Completed Results FDA Device

• 1 other identifier: VP-0714
• Study Type: interventional
• Target: 61
• Locations: 1 country
• Sites: 4

Brief Summary

A prospective, open label, multi-center, single arm, observational study designed to evaluate the acute safety and device procedural success of the Sapphire II PRO 1.0 and 1.25 mm PTCA dilatation catheters in subjects with stenotic coronary arteries or bypass grafts during percutaneous coronary intervention. Sixty (60) subjects will be treated at up to 5 U.S. sites with the Sapphire II PRO diameters 1.0 and 1.25 mm PTCA dilatation catheters to pre-dilate coronary arteries or bypass grafts 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

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 TIMI flow from baseline related to the study balloon * Final TIMI flow grade of 3 at the conclusion of the PCI procedure

  Peri-procedural (at Day 0)

Secondary Outcomes (3)

• 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)

Study Arms (1)

Sapphire II PRO

EXPERIMENTAL

Single arm with investigational Sapphire II PRO 1.0 and 1.25 mm PTCA dilatation catheters

Device: Sapphire II PRO

Interventions

Sapphire II PRO DEVICE

To pre-dilate coronary arteries or bypass grafts during the subject's index procedure with Sapphire II PRO 1.0 and 1.25 PTCA dilatation catheters.

Sapphire II PRO

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.
• Subject must have de novo or restenotic lesion(s) in native coronary arteries or bypass grafts that are suitable for percutaneous coronary intervention. An embolic protection device must be used in all Saphenous venous grafts (SVG) interventions performed during the index procedure.
• A maximum of two lesions, including at least one target lesion, in up to two coronary arteries.
• Target and non-target lesions must be located in different coronary arteries or bypass grafts.
• Target lesion(s) must have a diameter stenosis of ≥70% by visual estimation and may include chronic total occlusions (CTO)
• Treatment of non-target lesion, if any, must be completed prior to treatment of target lesion and must be deemed a clinical angiographic success.

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 an acute myocardial infarction (AMI) within 72 hours prior to index procedure.
• 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 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.
• 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)

Sponsors & Collaborators

• OrbusNeich: lead
• Icahn School of Medicine at Mount Sinai: collaborator

Study Sites (4)

University of Miami

Miami, Florida, 33146, United States

Location

Piedmont Heart Institute

Atlanta, Georgia, 30309, United States

Location

Peninsula Regional Medical Center

Salisbury, Maryland, 21801, United States

Location

The Christ Hospital Heart and Vascular

Cincinnati, Ohio, 45219, United States

Location

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: Debbie Morrell, Clinical Research Manager
• Organization: OrbusNeich

DMorrell@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: February 7, 2017
• First Posted: February 14, 2017
• Study Start: May 5, 2017
• Primary Completion: July 24, 2017
• Study Completion: July 24, 2017
• Last Updated: May 11, 2018
• Results First Posted: April 4, 2018

Record last verified: 2018-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (4)