Scoreflex TRIO - Scoring PTCA Catheter

NCT05929313 | Completed

• 1 other identifier: SFT-2022-001
• Study Type: interventional
• Target: 210
• Locations: 1 country
• Sites: 4

Brief 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.

Conditions

Coronary Arteriosclerosis

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Rate of device Procedural Success

  Device procedural success consisting of the following: * Successful delivery, inflation, deflation, and withdrawal of the device * 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 devices * Residual stenosis of target lesion \<50% after balloon angioplasty, Final TIMI flow grade of 3 at the conclusion of the percutaneous coronary intervention (PCI) procedure

  Peri-procedural (at Day 0)

Secondary Outcomes (4)

• Improvement in Minimum Lumen Diameter (MLD) following use of Scoreflex NC catheter (measured by QCA).

  Peri-procedural (at Day 0)

• In-hospital Major Adverse Cardiac Events (MACE)

  Endpoints will be measured through hospital discharge (expected to be within 24 hours)

• Device-oriented target lesion failure (TLF)

  30 days

• Patient-oriented composite endpoint

  30 days

Study Arms (2)

OrbusNeich Scoreflex TRIO

EXPERIMENTAL

OrbusNeich Scoreflex TRIO Scoring PTCA catheters

Device: OrbusNeich Scoreflex TRIO

OrbusNeich Scoreflex NC

ACTIVE COMPARATOR

OrbusNeich Scoreflex NC Scoring PTCA catheters

Device: OrbusNeich Scoreflex NC

Interventions

OrbusNeich Scoreflex TRIO DEVICE

To dilate coronary arteries during the subject's index procedure with Scoreflex TRIO Scoring PTCA catheters

OrbusNeich Scoreflex TRIO

OrbusNeich Scoreflex NC DEVICE

To dilate coronary arteries during the subject's index procedure with Scoreflex NC Scoring PTCA catheters

OrbusNeich Scoreflex NC

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• Planned or actual target lesion treatment with an unapproved device, atherectomy, laser, cutting balloon or thrombectomy during the index procedure.
• Subjects who are participating in clinical research of other drugs and devices.
• Other conditions assessed by the investigator as inappropriate to participate in this trial.
• Target lesion longer than 30 mm by visual estimation.
• Extreme angulation (90º or greater) proximal to or within the target lesion.
• Target lesion located within an arterial or saphenous vein graft or graft anastomosis
• 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.

Sponsors & Collaborators

• OrbusNeich: lead
• CCRC Medtech (Shanghai) Co., Ltd.: collaborator

Study Sites (4)

Sir Run Run Shaw Hospital Zhejiang University School of Medicine

Hangzhou, Zhejiang, China

Location

The Second Affiliated Hospital Zhejiang University School of Medicine

Hangzhou, Zhejiang, China

Location

Tong Ren Hospital Shanghai Jiao Tong University School of Medicine

Shanghai, China

Location

Zhongshan Hospital Fudan University

Shanghai, China

Location

MeSH Terms

Conditions

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

Condition Hierarchy (Ancestors)

Arterial Occlusive Diseases; Vascular Diseases

Study Officials

• Jun Bo Ge, MD

  Fudan University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 23, 2023
• First Posted: July 3, 2023
• Study Start: April 27, 2023
• Primary Completion: April 30, 2024
• Study Completion: May 29, 2024
• Last Updated: August 26, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

CN (4)