Scoreflex NC - Scoring PTCA Catheter

OrbusNeich

Status: Completed

Conditions: Coronary Artery Disease; Myocardial Ischemia; Cardiovascular Diseases; Arteriosclerosis; Heart Diseases; Coronary Disease

Treatments: Device: Scoreflex NC Scoring PTCA catheter

Study type: Interventional

Funder types: Industry

Identifiers

NCT03763747

VP-0730

Details and patient eligibility

About

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.

Enrollment: 200 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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200 participants in 1 patient group

Scoreflex NC Scoring PTCA Catheter

Experimental group

Description:

Single arm with investigational Scoreflex NC Scoring PTCA catheters

Treatment:

Device: Scoreflex NC Scoring PTCA catheter