CompletedNot Applicable

Scoreflex TRIO - Scoring PTCA Catheter

China210 participantsStarted 2023-04-27

Plain-language summary

To evaluate the acute safety and device procedural success of the Scoreflex TRIO Scoring PTCA catheters versus Scoreflex NC Scoring PTCA catheters in subjects with stenotic coronary arteries during percutaneous coronary intervention.

Who can participate

Age range18 Years – 80 Years

SexALL

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Inclusion criteria

✓. Age ≥ 18 and≤ 80.
✓. Volunteer to participate in this trial and provide the written informed consent.
✓. 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, need percutaneous coronary intervention.
✓. Subject must have de novo or restenotic lesion(s) in native coronary arteries, including in-stent restenosis suitable for percutaneous coronary intervention.
✓. A maximum of two lesions that needed to be treated and they are located in two coronary arteries, including at least one target lesion, in up to two coronary arteries.
✓. Target lesion must have a reference vessel diameter (RVD) between 1.75 and 4.0 mm by visual estimation.
✓. Target lesion(s) must have a diameter stenosis of ≥70% by visual estimation.
✓. The non-target lesion must be located in different coronary artery from the Target lesion. 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.

Exclusion criteria

✕. STEMI or NSTEMI within 7 days of study screening.
✕. A serum creatinine level \> 2.0 mg/dl within 7 days prior to index procedure.
✕. Cerebrovascular accident (CVA) within the past 6 months.
✕. Active peptic ulcer or active gastrointestinal (GI) bleeding within the past 6 months.
✕. Left ventricular ejection fraction (LVEF) \<30% (LVEF may be obtained at the time of the index procedure if the value is unknown, if necessary)
✕. Subject with a known hypersensitivity or contraindication to aspirin, heparin, bivalirudin, anti-platelet medications,
✕. Subject is known to be allergic to the ingredients of the test product and the sensitivity to contrast media.
✕. 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.

What they're measuring

Rate of device Procedural Success

Timeframe: Peri-procedural (at Day 0)

Trial details

NCT IDNCT05929313

SponsorOrbusNeich

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2024-04-30

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