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Coronary Crossing System in Patients With Coronary Chronic Total Occlusions | Clinical Trials | Clareo Health

RECRUITINGNA

Coronary Crossing System in Patients With Coronary Chronic Total Occlusions

A Prospective, Multicenter Clinical Trial in Evaluating the Safety and Efficacy of the Coronary Crossing System in Patients With Coronary Chronic Total Occlusions

NCT05813704•Shanghai MicroPort Rhythm MedTech Co., Ltd.

View on ClinicalTrials.gov

Summary

This is a prospective and multicenter clinical investigation aiming to evaluate the safety and effectiveness of coronary crossing system for the treatment of patients with coronary chronic total occlusions.

Detailed Description

This study is divided into two phases. The first phase is the pilot study stage, which is a prospective single-group observational test (FIM phase). The second phase is the pivotal study phase, which is a prospective, multi-center, single-group clinical trial (OPC phase). It is carried out in about 20 hospitals in China. 1. Pilot study phase (FIM phase): It is a prospective single-group observational test. It is expected to recruit 10 subjects in a research center in China. 2. Pivotal study phase (OPC phase): It is a prospective, multicenter, single-group clinical trial. 146 subjects are expected to be recruited in 20 research centers in China. 3. All subjects with coronary chronic total occlusions participating in this clinical study must have only a CTO lesion which occluded in length of more than 5 mm and located in a native coronary artery with a diameter of ≥ 2.50 mm (visual inspection). 4. All subjects receive clinical follow-up during hospitalization, 30 days after surgery.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Aged 18 years and older.
•2. Subjects with coronary artery disease who have symptoms of angina pectoris and evidence of ischemia or myocardial viability in the area innervated by the coronary arteries where the CTO is located.
•3. Subjects who are able to understand the purpose of the trial, participate voluntarily or by proxy and indicate by signing the informed consent form that they recognize the risks and benefits described in the informed consent document and are willing to undergo clinical follow-up.
•1. There is only one target CTO that needs to be treated with percutaneous coronary intervention (PCI).
•2. Target CTO is located in a native coronary artery with a reference vessel diameter of ≥ 2.5 mm.
•3. Angiography showed complete occlusion of the target CTO (visual inspection), antegrade flow of the occluded vessel segment TIMI grade 0 and inferred occlusion time ≥ 3 months; or previous angiographic records confirmed occluded time of the target CTO ≥ 3 months.
•4. The target CTO occluded segment length ≥ 5 mm (visual inspection).
•5. Angiography of the target CTO showed high density along the vessel, which is considered calcified lesion.
•6. The antegrade approach is determined as the primary strategy with guidewire crossing in PCI treatment.
•7. The fibrous cap of the target lesion can not be penetrated within 60 seconds using the guidewire with polypolymer coated or tip stiffness \> 1.5g (visual inspection) under fluoroscopy and the time is timed when the guidewire reaches the fibrous cap. (To identify chronic total occlusions and exclude acute or subacute occlusions that such guidewire can pass directly).
+1 more criteria

Exclusion Criteria

•1. Acute myocardial infarction within 30 days prior to baseline procedure.
•2. Life expectancy \< 1 year.
•3. Inability to use protocol-required concomitant medications (eg, aspirin, P2Y12 platelet receptor inhibitors, heparin, contrast agents, etc) due to allergy or other contraindications, and no alternative medications.
•4. The target CTO has an iatrogenic dissection that occurred within the past 3 months.
•5. Left ventricular ejection fraction less than 35%.
•6. Severe aortic or mitral valve disease.
•7. Planned left ventricular (LV) support device during CTO PCI.
•8. Subjects with clear bleeding tendency, contraindications to antiplatelet agents and anticoagulant therapy.
•9. Stroke, transient ischemic attack (TIA), or significant gastrointestinal (GI) bleeding within 6 months before the baseline procedure.
•10. Planned additional coronary or valvular percutaneous or surgical intervention scheduled within 30 days after baseline procedure.
+11 more criteria

Locations (1)

Zhongshan Hospital of Fudan University

Shanghai, China

Key Dates

Start Date

November 7, 2023

Primary Completion Date

April 1, 2025

Completion Date

May 1, 2025

Last Updated

March 18, 2024

Enrollment

156

ESTIMATED participants

Conditions

Chronic Total Occlusion of Coronary Artery

Interventions

Coronary Crossing System of Shanghai MicroPort Rhythm

DEVICE

Contacts

Tingting Wu, M.D.

CONTACT

0086-021-38954600 TingTing.Wu2@microport.com

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: March 18, 2024Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

Coronary Crossing System in Patients With Coronary Chronic Total Occlusions

Inclusion Criteria

Exclusion Criteria

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