Scoreflex NC - Scoring PTCA Catheter

• Sponsor: OrbusNeich (Industry)
• Overall Status: Completed
• CT.gov ID: NCT03763747
• Collaborator: ClinLogix. LLC (Industry)
• Enrollment: 200
• Locations: 9
• Arm: 1
• Actual Duration (Months): 10
• Patients Per Site: 22.2
• Patients Per Site Per Month: 2.2

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 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.

Condition or Disease	Intervention/Treatment	Phase
Coronary Artery Disease; Coronary Disease; Myocardial Ischemia; Heart Diseases; Arteriosclerosis; Cardiovascular Diseases	Device: Scoreflex NC Scoring PTCA catheter	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 200 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Scoreflex NC - Scoring PTCA Catheter: A Prospective, Open Label, Multi-center, Single Arm, Observational Study Designed to Evaluate the Safety and Device Procedural Success of the Scoreflex NC Scoring PTCA Catheter in Subjects With Stenotic Coronary Arteries During Percutaneous Coronary Intervention.
• Actual Study Start Date: Feb 27, 2019
• Actual Primary Completion Date: Dec 27, 2019
• Actual Study Completion Date: Dec 27, 2019

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Scoreflex NC Scoring PTCA Catheter Single arm with investigational Scoreflex NC Scoring PTCA catheters	Device: Scoreflex NC Scoring PTCA catheter; To dilate coronary arteries during the subject's index procedure with Scoreflex NC Scoring PTCA 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 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

Secondary Outcome Measures

1. Number of Participants With Angiographic Procedural Success [Peri-procedural (at Day 0)]

   Angiographic Procedural Success defined as Final diameter stenosis ≤ 50% in at least one of the Scoreflex NC attempted lesions following completion of the interventional procedure, including adjunctive stenting

2. 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), a composite of: All death (cardiac and non-cardiac) Myocardial infarction (MI) Target Lesion Revascularization (TLR), clinically indicated

3. 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

4. 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)

5. Number of Scoreflex NC Scoring Catheters That Had Occurrence of Balloon Rupture [Peri-procedural]

   Occurrence of Scoreflex NC Study Balloon rupture

6. Number of Participants That Had Improvement in Minimum Lumen Diameter (MLD) Following Use of Scoreflex NC Catheter (Measured by Quantitative Coronary Angiography (QCA)) [Peri-procedural]

   Improvement in Minimum Lumen Diameter (MLD) following use of Scoreflex NC catheter (measured by QCA). Improvement in MLD is defined as MLD post use of Scoreflex as greater than MLD from baseline.

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

Angiographic Inclusion Criteria

1. Subject must have de novo or restenotic lesion(s) in native coronary arteries, including in-stent restenosis suitable for percutaneous coronary intervention.

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

3. Target lesion must have a reference vessel diameter (RVD) between 1.75 and 4.0 mm by visual estimation.

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

5. The non-target lesion must be located in different coronary artery from the Target lesion.

6. 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.

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 STEMI or NSTEMI at index presentation or within 7 days of study screening.

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 7 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. Target lesion located within an arterial or saphenous vein graft or graft anastomosis

Angiographic Exclusion Criteria

1. More than two lesions requiring treatment.

2. Target lesion longer than 30 mm by visual estimation.

3. Extreme angulation (90º or greater) proximal to or within the target lesion.

4. 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.

5. Target lesion demonstrating severe dissection prior to planned deployment of the Scoreflex NC device

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

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

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

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

10. 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	The Cardiac and Vascular Institute Research Foundation	Gainesville	Florida	United States	32605
2	University of Miami	Miami	Florida	United States	33136
3	Piedmont Heart Institute	Atlanta	Georgia	United States	30309
4	Atlanta VA Healthcare System	Decatur	Georgia	United States	30033
5	Delmarva Heart Research Foundation Inc./Peninsula Regional Medical Center	Salisbury	Maryland	United States	21804
6	CentraCare Heart and Vascular Center	Saint Cloud	Minnesota	United States	56303
7	Cardiology Associates Research, LLC	Tupelo	Mississippi	United States	38801
8	Deborah Heart and Lung Center	Browns Mills	New Jersey	United States	08015
9	The Lindner Research Center/The Christ Hospital Heart and Vascular	Cincinnati	Ohio	United States	45219

Sponsors and Collaborators

• OrbusNeich
• ClinLogix. LLC

Investigators

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

Study Documents (Full-Text)

• Study Protocol - Nov 30, 2018
• Statistical Analysis Plan - May 28, 2020

More Information

Publications

None provided.

• Responsible Party: OrbusNeich
• ClinicalTrials.gov Identifier: NCT03763747
• Other Study ID Numbers: VP-0730
• First Posted: Dec 4, 2018
• Last Update Posted: Aug 11, 2021
• Last Verified: Jul 1, 2021

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: Yes
• Keywords provided by OrbusNeich: Coronary Artery Disease; Coronary Disease; Myocardial Ischemia; Heart Diseases; Arteriosclerosis; Cardiovascular Diseases
• Additional relevant MeSH terms: Cardiovascular Diseases; Coronary Artery Disease; Myocardial Ischemia; Coronary Disease; Heart Diseases; Arteriosclerosis; Ischemia

Study Results

Participant Flow

Arm/Group Title	Scoreflex NC Scoring Percutaneous Transluminal Coronary Angioplasty (PTCA) Catheter
Arm/Group Description	Single arm with investigational Scoreflex NC Scoring PTCA catheters Scoreflex NC Scoring PTCA catheter: To dilate coronary arteries during the subject's index procedure with Scoreflex NC Scoring PTCA catheters
Period Title: Overall Study
STARTED	200
COMPLETED	200
NOT COMPLETED	0

Baseline Characteristics

Arm/Group Title	Scoreflex NC Scoring PTCA Catheter
Arm/Group Description	Single arm with investigational Scoreflex NC Scoring PTCA catheters Scoreflex NC Scoring PTCA catheter: To dilate coronary arteries during the subject's index procedure with Scoreflex NC Scoring PTCA catheters
Overall Participants	200
Overall Lesions	221
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	67.3 (8.98)
Sex: Female, Male (Count of Participants)
Female	46 23%
Male	154 77%
Race/Ethnicity, Customized (Count of Participants)
Asian	2 1%
Black	18 9%
White	178 89%
Native Hawaiian/Pacific Islander	1 0.5%
American Indian/Alaska Native	0 0%
Other	1 0.5%
Region of Enrollment (Count of Participants)
United States	200 100%
Cardiac History (Count of Participants)
Prior Percutaneous Coronary Intervention	106 53%
Prior Coronary Artery Bypass Graft	26 13%
Prior Myocardial Infarction	61 30.5%
Current Cardiac Status (Count of Participants)
Asymptomatic	18 9%
Silent Ischemia	8 4%
Stable Angina	116 58%
Unstable Angina	57 28.5%
ST-Elevation Myocardial Infarction (STEMI)	1 0.5%
Cardiac Risk Factors (Count of Participants)
Cigarette Smoking (within 30 days)	37 18.5%
Diabetes Mellitus	88 44%
Diabetes Mellitus (Insulin requiring)	20 10%
Hypercholesterolemia Requiring Treatment	181 90.5%
Hypertension Requiring Treatment	182 91%
Angiographic Characteristics: Vessel Location (Core Lab assessed) (Lesions) [Count of Units]
Left Anterior Descending Artery (LAD)	97
Left Circumflex Artery (LCX)	55
Right Coronary Artery (RCA)	68
Not Identified	1
Angiographic Characteristics: Lesion Location (Core Lab assessed) (Lesions) [Count of Units]
Ostial	7
Proximal	98
Middle	93
Distal	23
Angiographic Characteristics: Lesion Characteristics (Core Lab assessed) (Millimeters) [Mean (Standard Deviation) ]
Lesion Length	18.37 (12.93)
Minimal Luminal Diameter	0.8 (0.40)
Angiographic Characteristics: Lesion Characteristics (Core Lab assessed) (Lesions) [Count of Units]
Moderate/Severe Calcification	81
Moderate/Severe Tortuosity	7
Total Occlusion	11
Baseline Thrombolysis in Myocardial Infarction (TIMI) Flow (Core Lab assessed) (Lesions) [Count of Units]
0 (no perfusion)	6
1 (penetration with minimal perfusion)	5
2 (partial perfusion)	6
3 (complete perfusion)	204
Angiographic Characteristics: Bifurcations, Medina Type (Core Lab assessed) (Lesions) [Count of Units]
0,0,0	2
0,0,1	3
0,1,0	38
1,0,0	16
0,1,1	8
1,0,1	3
1,1,0	8
1,1,1	6
Non-bifurcation lesions	137

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 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
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	Scoreflex NC Scoring PTCA Catheter
Arm/Group Description	Single arm with investigational Scoreflex NC Scoring PTCA catheters Scoreflex NC Scoring PTCA catheter: To dilate coronary arteries during the subject's index procedure with Scoreflex NC Scoring PTCA catheters
Measure Participants	200
Count of Participants [Participants]	187 93.5%

2. Secondary Outcome

Title	Number of Participants With Angiographic Procedural Success
Description	Angiographic Procedural Success defined as Final diameter stenosis ≤ 50% in at least one of the Scoreflex NC attempted lesions following completion of the interventional procedure, including adjunctive stenting
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	Scoreflex NC Scoring PTCA Catheter
Arm/Group Description	Single arm with investigational Scoreflex NC Scoring PTCA catheters Scoreflex NC Scoring PTCA catheter: To dilate coronary arteries during the subject's index procedure with Scoreflex NC Scoring PTCA catheters
Measure Participants	200
Count of Participants [Participants]	197 98.5%

3. Secondary Outcome

Title	Number of Participants With In-hospital Major Adverse Cardiac Events (MACE)
Description	In-hospital Major Adverse Cardiac Events (MACE), a composite of: All death (cardiac and non-cardiac) Myocardial infarction (MI) Target Lesion Revascularization (TLR), clinically indicated
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	Scoreflex NC Scoring PTCA Catheter
Arm/Group Description	Single arm with investigational Scoreflex NC Scoring PTCA catheters Scoreflex NC Scoring PTCA catheter: To dilate coronary arteries during the subject's index procedure with Scoreflex NC Scoring PTCA catheters
Measure Participants	200
Count of Participants [Participants]	9 4.5%

4. 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	Scoreflex NC Scoring PTCA Catheter
Arm/Group Description	Single arm with investigational Scoreflex NC Scoring PTCA catheters Scoreflex NC Scoring PTCA catheter: To dilate coronary arteries during the subject's index procedure with Scoreflex NC Scoring PTCA catheters
Measure Participants	200
Count of Participants [Participants]	0 0%

5. 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	Scoreflex NC Scoring PTCA Catheter
Arm/Group Description	Single arm with investigational Scoreflex NC Scoring PTCA catheters Scoreflex NC Scoring PTCA catheter: To dilate coronary arteries during the subject's index procedure with Scoreflex NC Scoring PTCA catheters
Measure Participants	200
Count of Participants [Participants]	1 0.5%

6. Secondary Outcome

Title	Number of Scoreflex NC Scoring Catheters That Had Occurrence of Balloon Rupture
Description	Occurrence of Scoreflex NC Study Balloon rupture
Time Frame	Peri-procedural

Outcome Measure Data

Analysis Population Description

Analysis population consists of intent-to-treat subject population. Site reported data represented on the use of 239 Scoreflex NC Scoring PTCA catheter study devices.

Arm/Group Title	Scoreflex NC Scoring PTCA Catheter
Arm/Group Description	Single arm with investigational Scoreflex NC Scoring PTCA catheters Scoreflex NC Scoring PTCA catheter: To dilate coronary arteries during the subject's index procedure with Scoreflex NC Scoring PTCA catheters
Measure Participants	200
Measure Scoreflex NC Scoring PTCA catheters	239
Count of Units [Scoreflex NC Scoring PTCA catheters]	2

7. Secondary Outcome

Title	Number of Participants That Had Improvement in Minimum Lumen Diameter (MLD) Following Use of Scoreflex NC Catheter (Measured by Quantitative Coronary Angiography (QCA))
Description	Improvement in Minimum Lumen Diameter (MLD) following use of Scoreflex NC catheter (measured by QCA). Improvement in MLD is defined as MLD post use of Scoreflex as greater than MLD from baseline.
Time Frame	Peri-procedural

Outcome Measure Data

Analysis Population Description

Analysis population consists of intent-to-treat subject population. Please note that the data for Number of Participants that had Improvement in Minimum Lumen Diameter was not analyzable in 23 patients by the Angiographic Core Lab.

Arm/Group Title	Scoreflex NC Scoring PTCA Catheter
Arm/Group Description	Single arm with investigational Scoreflex NC Scoring PTCA catheters Scoreflex NC Scoring PTCA catheter: To dilate coronary arteries during the subject's index procedure with Scoreflex NC Scoring PTCA catheters
Measure Participants	177
Count of Participants [Participants]	161 80.5%

Adverse Events

Time Frame	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	Scoreflex NC Scoring PTCA Catheter
Arm/Group Description	Single arm with investigational Scoreflex NC Scoring PTCA catheters Scoreflex NC Scoring PTCA catheter: To dilate coronary arteries during the subject's index procedure with Scoreflex NC Scoring PTCA catheters
All Cause Mortality
	Scoreflex NC Scoring PTCA Catheter
	Affected / at Risk (%)	# Events
Total	0/200 (0%)
Serious Adverse Events
	Scoreflex NC Scoring PTCA Catheter
	Affected / at Risk (%)	# Events
Total	1/200 (0.5%)
Cardiac disorders
Target Lesion Revascularization Clinically Indicated TLR)	1/200 (0.5%)	1
Myocardial Infarction (Non Q-wave)	1/200 (0.5%)	1
Other (Not Including Serious) Adverse Events
	Scoreflex NC Scoring PTCA Catheter
	Affected / at Risk (%)	# Events
Total	8/200 (4%)
Cardiac disorders
Myocardial Infarction (Non Q-wave)	7/200 (3.5%)	7
Clinically Significant Arrhythmias (Requiring Intervention)	1/200 (0.5%)	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.