Coronary Crossing System in Patients With Coronary Chronic Total Occlusions

NCT05813704 | Recruiting

• 1 other identifier: AMD-D-003
• Study Type: interventional
• Target: 156
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Chronic Total Occlusion of Coronary Artery

Keywords

chronic total occlusions; coronary artery

Outcome Measures

Primary Outcomes (1)

• Device success

  Device success is defined as successful antegrade crossing of the CTO into the true arterial lumen distal to the occlusion following advancement of at least 3 mm of the Coronary Crossing System into any segment as assessed by the core angiographic laboratory. (An antegrade only approach may involve Antegrade Dissection Re-Entry (ADR) with or without the use of specialized devices (e.g. Stingray); absence of successful retrograde crossing of a collateral will still be considered an antegrade only approach.)

  Baseline procedure

Secondary Outcomes (6)

• Overall device success

  Baseline procedure

• Technical Success

  Baseline procedure

• Procedural Success

  Baseline procedure

• Clinical Success

  30 days post-procedure

• Freedom from device related major adverse event(MAE)

  48 hours or until discharge

Study Arms (1)

Coronary Crossing System

EXPERIMENTAL

Subjects in experimental group will be treated with the Coronary Crossing System manufactured by Shanghai Microport Rhythm Co. Ltd.

Device: Coronary Crossing System of Shanghai MicroPort Rhythm

Interventions

Coronary Crossing System of Shanghai MicroPort Rhythm DEVICE

The mechanical vibration generated by the Coronary Crossing System through the piezoelectric effect is amplified and transmitted to the distal end of the guidewire to achieve high-frequency vibration at the tip of the guidewire, and then achieve efficient and safe penetration of the fibrous cap of the CTO.

Coronary Crossing System

Eligibility Criteria

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

You may qualify if:

• Aged 18 years and older.
• 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.
• 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.
• There is only one target CTO that needs to be treated with percutaneous coronary intervention (PCI).
• Target CTO is located in a native coronary artery with a reference vessel diameter of ≥ 2.5 mm.
• 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.
• The target CTO occluded segment length ≥ 5 mm (visual inspection).
• Angiography of the target CTO showed high density along the vessel, which is considered calcified lesion.
• The antegrade approach is determined as the primary strategy with guidewire crossing in PCI treatment.
• 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).
• In addition to the target lesion, there must be up to one non-target lesion to be treated and it is located on a different epicardial vessel than the target lesion. Target lesions can be treated after successful treatment of the non-target lesion (residual stenosis \< 30% and TIMI 3 flow) without complications.

You may not qualify if:

• Acute myocardial infarction within 30 days prior to baseline procedure.
• Life expectancy \< 1 year.
• 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.
• The target CTO has an iatrogenic dissection that occurred within the past 3 months.
• Left ventricular ejection fraction less than 35%.
• Severe aortic or mitral valve disease.
• Planned left ventricular (LV) support device during CTO PCI.
• Subjects with clear bleeding tendency, contraindications to antiplatelet agents and anticoagulant therapy.
• Stroke, transient ischemic attack (TIA), or significant gastrointestinal (GI) bleeding within 6 months before the baseline procedure.
• Planned additional coronary or valvular percutaneous or surgical intervention scheduled within 30 days after baseline procedure.
• Subjects who require emergent or urgent PCI.
• Female subjects who are pregnant or breast-feeding.
• Subjects who are participating in another investigational drug or device clinical trial in which the primary endpoint is still not reached, or intend to participate in another investigational drug or device clinical trial within 12 months after baseline procedure.
• Other medical illnesses that may cause the subject to be non-compliant with the protocol or confound data interpretation.
• Serum creatinine \> 2.5 mg/dL (or 221 µmol/L), or on dialysis.

Sponsors & Collaborators

• Shanghai MicroPort Rhythm MedTech Co., Ltd.: lead
• Shanghai Zhongshan Hospital: collaborator
• Xiamen Cardiovascular Hospital, Xiamen University: collaborator
• Shanghai Baoshan District Wusong Central Hospital: collaborator
• Union Hospital, Tongji Medical College, Huazhong University of Science and Technology: collaborator
• The First Affiliated Hospital of Nanchang University: collaborator
• First Affiliated Hospital Xi'an Jiaotong University: collaborator
• First Affiliated Hospital of Wenzhou Medical University: collaborator
• Tianjin First Central Hospital: collaborator
• The Affiliated Hospital Of Southwest Medical University: collaborator
• Hebei General Hospital: collaborator
• West China Hospital: collaborator
• First Affiliated Hospital of Army Medical University, PLA: collaborator
• Lanzhou University First Hospital: collaborator
• Nanfang Hospital, Southern Medical University: collaborator
• The Second Affiliated Hospital of Dalian Medical University: collaborator
• Xinhua Hospital, Shanghai Jiao Tong University School of Medicine: collaborator

Study Sites (1)

Zhongshan Hospital of Fudan University

Shanghai, China

RECRUITING

Study Officials

• Junbo Ge, M.D.

  Fudan University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Tingting Wu, M.D.

CONTACT

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

Study Design

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

Study Record Dates

• First Submitted: April 3, 2023
• First Posted: April 14, 2023
• Study Start: November 7, 2023
• Primary Completion: April 1, 2025
• Study Completion: May 1, 2025
• Last Updated: March 18, 2024

Record last verified: 2024-03

Locations

CN (1)