Sapphire II PRO US Clinical Study

• Sponsor: OrbusNeich (Industry)
• Overall Status: Completed
• CT.gov ID: NCT03052530
• Collaborator: Icahn School of Medicine at Mount Sinai (Other)
• Enrollment: 61
• Locations: 4
• Arm: 1
• Actual Duration (Months): 2.6
• Patients Per Site: 15.3
• Patients Per Site Per Month: 5.8

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Coronary Artery Disease; Coronary Disease; Myocardial Ischemia; Heart Diseases; Arteriosclerosis; Cardiovascular Diseases	Device: Sapphire II PRO	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 61 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Sapphire II PRO - 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.
• Actual Study Start Date: May 5, 2017
• Actual Primary Completion Date: Jul 24, 2017
• Actual Study Completion Date: Jul 24, 2017

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Sapphire II PRO Single arm with investigational Sapphire II PRO 1.0 and 1.25 mm PTCA dilatation catheters	Device: 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.

Outcome Measures

Primary Outcome Measures

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

Secondary Outcome Measures

1. 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) All death (cardiac and non-cardiac) Myocardial infarction (MI) Target Lesion Revascularization (TLR)

2. 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

3. 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)

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Clinical 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.

Angiographic Inclusion Criteria

1. 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.

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

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

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

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

Clinical 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)

Angiographic Exclusion Criteria

1. More than two lesions requiring treatment.

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

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

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

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

6. 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Miami	Miami	Florida	United States	33146
2	Piedmont Heart Institute	Atlanta	Georgia	United States	30309
3	Peninsula Regional Medical Center	Salisbury	Maryland	United States	21801
4	The Christ Hospital Heart and Vascular	Cincinnati	Ohio	United States	45219

Sponsors and Collaborators

• OrbusNeich
• Icahn School of Medicine at Mount Sinai

Investigators

• Principal Investigator: David Kandzari, MD, Piedmont Heart Institute

Study Documents (Full-Text)

• Study Protocol - Feb 16, 2017
• Statistical Analysis Plan - Sep 25, 2017

More Information

Publications

None provided.

• Responsible Party: OrbusNeich
• ClinicalTrials.gov Identifier: NCT03052530
• Other Study ID Numbers: VP-0714
• First Posted: Feb 14, 2017
• Last Update Posted: May 11, 2018
• Last Verified: Apr 1, 2018

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: Yes
• Additional relevant MeSH terms: Cardiovascular Diseases; Coronary Artery Disease; Myocardial Ischemia; Coronary Disease; Heart Diseases; Arteriosclerosis; Ischemia

Study Results

Participant Flow

Arm/Group Title	Sapphire II PRO
Arm/Group Description	Single arm with investigational Sapphire II PRO 1.0 and 1.25 mm PTCA dilatation catheters 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.
Period Title: Overall Study
STARTED	61
COMPLETED	61
NOT COMPLETED	0

Baseline Characteristics

Arm/Group Title	Sapphire II PRO
Arm/Group Description	Single arm with investigational Sapphire II PRO 1.0 and 1.25 mm PTCA dilatation catheters
Overall Participants	61
Age (Years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [Years]	67.26 (9.35)
Sex: Female, Male (Count of Participants)
Female	11 18%
Male	50 82%
Race/Ethnicity, Customized (Count of Participants)
Asian	1 1.6%
Black	3 4.9%
White	57 93.4%
Region of Enrollment (Count of Participants)
United States	61 100%
Cardiac History (Count of Participants)
Previous Percutaneous Coronary Intervention	31 50.8%
Previous Coronary Artery Bypass Graft	18 29.5%
Previous Myocardial Infarction	25 41%
Stable Angina	31 50.8%
Unstable Angina	21 34.4%
Cardiac Risk Factors (Count of Participants)
Current Cigarette Smoking (within 30 days)	10 16.4%
Medically Treated Diabetes	16 26.2%
Hypercholesterolemia Requiring Treatment	55 90.2%
Hypertension Requiring Treatment	51 83.6%
Lesion Characteristics: Vessel Treated (Lesions) [Number]
Bypass Graft	4
Diagonol Branch-Left Anterior Descending Artery	10
Left Anterior Descending Artery	22
Left Circumflex Artery	12
Marginal Branch of Left Circumflex Artery	1
Posterior Descending Branch-Right Coronary Artery	2
Right Coronary Artery	16
Lesion Characteristics: Lesion Location (Lesions) [Number]
Distal	11
Mid	27
Ostial	3
Prox	26
Lesion Characteristics (Millimeters) [Mean (Standard Deviation) ]
Lesion Length	18.42 (12.25)
Minimum Lumen Diameter	.52 (.35)
Lesion Characteristics (Lesions) [Number]
Thrombus	1
Tortuosity	0
Calcification	34
Ulceration	4
Aneurysm	0
Total Occlusion	9
Lesion Characteristics: Pre-Procedure Thrombolysis in Myocardial Infarction (TIMI) Flow (Lesions) [Number]
0 (no perfusion)	9
1 (penetration with minimal perfusion)	4
2 (partial perfusion)	4
3 (complete perfusion)	50

Outcome Measures

1. Primary Outcome

Title	Number of Participants With Device Procedural Success
Description	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
Time Frame	Peri-procedural (at Day 0)

Outcome Measure Data

Analysis Population Description

Analysis population consists of intent-to-treat subject population.

Arm/Group Title	Sapphire II PRO
Arm/Group Description	Single arm with investigational Sapphire II PRO 1.0 and 1.25 mm PTCA dilatation catheters
Measure Participants	61
Count of Participants [Participants]	59 96.7%

2. Secondary Outcome

Title	Number of Participants With In-hospital Major Adverse Cardiac Events (MACE)
Description	In-hospital Major Adverse Cardiac Events (MACE) All death (cardiac and non-cardiac) Myocardial infarction (MI) Target Lesion Revascularization (TLR)
Time Frame	Endpoints will be measured through hospital discharge (expected to be within 24 hours)

Outcome Measure Data

Analysis Population Description

Analysis population consists of intent-to-treat subject population.

Arm/Group Title	Sapphire II PRO
Arm/Group Description	Single arm with investigational Sapphire II PRO 1.0 and 1.25 mm PTCA dilatation catheters
Measure Participants	61
Count of Participants [Participants]	1 1.6%

3. Secondary Outcome

Title	Number of Participants With In-hospital Stent Thrombosis (ST) Within the Target Vessel
Description	In-hospital stent thrombosis (ST) within the target vessel
Time Frame	Endpoint will be measured through hospital discharge (expected to be within 24 hours)

Outcome Measure Data

Analysis Population Description

Analysis population consists of intent-to-treat subject population.

Arm/Group Title	Sapphire II PRO
Arm/Group Description	Single arm with investigational Sapphire II PRO 1.0 and 1.25 mm PTCA dilatation catheters
Measure Participants	61
Count of Participants [Participants]	0 0%

4. Secondary Outcome

Title	Number of Participants With Clinically Significant Arrhythmias (Requiring Intervention)
Description	Clinically Significant Arrhythmias (requiring intervention)
Time Frame	Endpoint will be measured through hospital discharge (expected to be within 24 hours)

Outcome Measure Data

Analysis Population Description

Analysis population consists of intent-to-treat subject population.

Arm/Group Title	Sapphire II PRO
Arm/Group Description	Single arm with investigational Sapphire II PRO 1.0 and 1.25 mm PTCA dilatation catheters
Measure Participants	61
Count of Participants [Participants]	0 0%

Adverse Events

Time Frame	Per the protocol, adverse events were collected from the point of subject enrollment through study completion at hospital discharge (hospital stay expected to be an average of 24 hours).
Arm/Group Title	Sapphire II PRO
Arm/Group Description	Single arm with investigational Sapphire II PRO 1.0 and 1.25 mm PTCA dilatation catheters
All Cause Mortality
	Sapphire II PRO
	Affected / at Risk (%)	# Events
Total	0/61 (0%)
Serious Adverse Events
	Sapphire II PRO
	Affected / at Risk (%)	# Events
Total	0/61 (0%)
Other (Not Including Serious) Adverse Events
	Sapphire II PRO
	Affected / at Risk (%)	# Events
Total	1/61 (1.6%)
Cardiac disorders
Myocardial infarction	1/61 (1.6%)	1

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.