Clinical trial NCT03763747: Scoreflex NC - Scoring PTCA Catheter
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.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Coronary Artery Disease
Coronary Disease
Myocardial Ischemia
Heart Diseases
Arteriosclerosis
Cardiovascular Diseases
Keywords: Coronary Artery Disease
Coronary Disease
Myocardial Ischemia
Heart Diseases
Arteriosclerosis
Cardiovascular Diseases
Lead sponsor: OrbusNeich
Sponsor class: INDUSTRY
Collaborators: name: ClinLogix. LLC
First posted: 2018-12-04
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility criteria: 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
5. Subject must have de novo or restenotic lesion(s) in native coronary arteries, including in-stent restenosis suitable for percutaneous coronary intervention.
6. A maximum of two lesions, including at least one target lesion, in up to two coronary arteries.
7. Target lesion must have a reference vessel diameter (RVD) between 1.75 and 4.0 mm by visual estimation.
8. Target lesion(s) must have a diameter stenosis of ≥70% by visual estimation and may include chronic total occlusions (CTO).
9. The non-target lesion must be located in different coronary artery from the Target lesion.
10. 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
10. More than two lesions requiring treatment.
11. Target lesion longer than 30 mm by visual estimation.
12. Extreme angulation (90º or greater) proximal to or within the target lesion.
13. 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.
14. Target lesion demonstrating severe dissection prior to planned deployment of the Scoreflex NC device
15. Unprotected left main coronary artery disease. (Greater than 50% diameter stenosis)
16. Coronary artery spasm of the target vessel in the absence of a significant stenosis.
17. Target lesion with angiographic presence of probable or definite thrombus.
18. Target lesion involves a bifurcation requiring treatment with more than one stent or pre-dilatation of a side branch \>2.0 mm in diameter.
19. 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

Primary outcomes:
measure: Number of Participants With Device Procedural Success
timeFrame: Peri-procedural (at Day 0)
Secondary outcomes:
measure: Number of Participants With Angiographic Procedural Success
timeFrame: Peri-procedural (at Day 0)
measure: Number of Participants With In-hospital Major Adverse Cardiac Events (MACE)
timeFrame: Endpoints will be measured through hospital discharge (expected to be within 24 hours)
measure: Number of Participants With In-hospital Stent Thrombosis (ST) Within the Target Vessel
timeFrame: Endpoint will be measured through hospital discharge (expected to be within 24 hours)
measure: Number of Participants With Clinically Significant Arrhythmias (Requiring Intervention)
timeFrame: Endpoint will be measured through hospital discharge (expected to be within 24 hours)
measure: Number of Scoreflex NC Scoring Catheters That Had Occurrence of Balloon Rupture
timeFrame: Peri-procedural
measure: Number of Participants That Had Improvement in Minimum Lumen Diameter (MLD) Following Use of Scoreflex NC Catheter (Measured by Quantitative Coronary Angiography (QCA))
timeFrame: Peri-procedural
Other outcomes:
Locations:
city: Gainesville
country: United States
facility: The Cardiac and Vascular Institute Research Foundation
state: Florida
city: Miami
country: United States
facility: University of Miami
state: Florida
city: Atlanta
country: United States
facility: Piedmont Heart Institute
state: Georgia
city: Decatur
country: United States
facility: Atlanta VA Healthcare System
state: Georgia
city: Salisbury
country: United States
facility: Delmarva Heart Research Foundation Inc./Peninsula Regional Medical Center
state: Maryland
city: Saint Cloud
country: United States
facility: CentraCare Heart and Vascular Center
state: Minnesota
city: Tupelo
country: United States
facility: Cardiology Associates Research, LLC
state: Mississippi
city: Browns Mills
country: United States
facility: Deborah Heart and Lung Center
state: New Jersey
city: Cincinnati
country: United States
facility: The Lindner Research Center/The Christ Hospital Heart and Vascular
state: Ohio
Study officials:
affiliation: Piedmont Heart Institute
name: David Kandzari, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Kandzari D, Hearne S, Kumar G, Sachdeva R, Adams G, Blossom B, Dahle T, Sanghvi K, Cohen MG, Imperi G, Riley R, Almonacid AP. Procedural Effectiveness With a Focused Force Scoring Angioplasty Catheter: Procedural and Clinical Outcomes From the Scoreflex NC Trial. Cardiovasc Revasc Med. 2022 Feb;35:85-90. doi: 10.1016/j.carrev.2021.03.013. Epub 2021 Mar 20.
citation: Louvard Y, Medina A. Definitions and classifications of bifurcation lesions and treatment. EuroIntervention. 2015;11 Suppl V:V23-6. doi: 10.4244/EIJV11SVA5.