Scoreflex NC - Scoring PTCA Catheter

Conditions:Angina, Peripheral Vascular Disease, Peripheral Vascular Disease, Peripheral Vascular Disease, Cardiology, Cardiology
Therapuetic Areas:Cardiology / Vascular Diseases
Age Range:18 - Any
Start Date:February 27, 2019
End Date:January 30, 2020
Contact:Debbie Morrell, MSME

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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.

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 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

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

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

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

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

- 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

- Treatment not deemed a clinical angiographic success
We found this trial at
Atlanta, Georgia 30309
Atlanta, GA
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Salisbury, MD
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