Sapphire II PRO US Clinical Study

NCT ID: NCT03052530

Last Updated: 2018-05-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 61 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-05-05
• Study Completion Date: 2017-07-24

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Sapphire II PRO

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

Group Type: EXPERIMENTAL

Sapphire II PRO

Intervention Type: 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.

Interventions

Sapphire II PRO

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.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

1. Subject is ≥ 18 years of age.

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 and clinical evidence of ischemic heart disease, such as stable / unstable angina or silent ischemia.

5. 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.

6. A maximum of two lesions, including at least one target lesion, in up to two coronary arteries.

7. Target and non-target lesions must be located in different coronary arteries or bypass grafts.

8. Target lesion(s) must have a diameter stenosis of ≥70% by visual estimation and may include chronic total occlusions (CTO)

9. Treatment of non-target lesion, if any, must be completed prior to treatment of target lesion and must be deemed a clinical angiographic success.

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

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 seven 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. More than two lesions requiring treatment.

10. Unprotected left main coronary artery disease.(Greater than 50% diameter stenosis)

11. Coronary artery spasm of the target vessel in the absence of a significant stenosis.

12. Target lesion with angiographic presence of probable or definite thrombus.

13. Target lesion involves a bifurcation requiring treatment with more than one stent or pre-dilatation of a side branch >2.0 mm in diameter.

14. 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Icahn School of Medicine at Mount Sinai

OTHER

Sponsor Role: collaborator

OrbusNeich

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

David Kandzari, MD

Role: PRINCIPAL_INVESTIGATOR

Piedmont Heart Institute

Locations

University of Miami

Miami, Florida, United States

Piedmont Heart Institute

Atlanta, Georgia, United States

Peninsula Regional Medical Center

Salisbury, Maryland, United States

The Christ Hospital Heart and Vascular

Cincinnati, Ohio, United States

Countries

United States

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

VP-0714

Identifier Type: -

Identifier Source: org_study_id