A Clinical Study for Pan-vascular Interventional Control System in Percutaneous Coronary Intervention
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Percutaneous Coronary Intervention
- Sponsor
- Shenzhen Institute of Advanced Biomedical Robot Co., Ltd.
- Enrollment
- 5
- Locations
- 2
- Primary Endpoint
- Technical Success
- Status
- Not yet recruiting
- Last Updated
- 2 years ago
Overview
Brief Summary
The goal of this prospective, single-center, single-arm study is to explore the efficacy and safety of the pan-vascular interventional robotic system for percutaneous coronary intervention (PCI), researchers will assess the clinical success, technical success, and record the intraoperative data (PCI time, guidewire operation time, dose of contrast medium, radiation exposure doses, etc). All subjects will be followed up on the day of surgery, before discharge (or 48 hours after surgery) and 1 month after surgery to observe the safety indicators.
Investigators
Ge Junbo
Chief of Cardiology
Shanghai Zhongshan Hospital
Eligibility Criteria
Inclusion Criteria
- •General Inclusion criteria:
- •18 years old ≤ age ≤80 years old;
- •have a clinical indication for PCI (clinical evidence of ischemic heart disease or a positive functional study);
- •Subjects or their legal representative has been informed of the nature of the study, signed informed consent and were willing to cooperate in the follow-up.
- •Angiographic inclusion criteria:
- •study lesion is a single de novo native coronary artery lesion (previously untreated coronary artery disease);
- •target vessel diameter between 2.5 mm and 4.0 mm;
- •single lesion length ≤38 mm, with at least 2.0 mm normal segments on the proximal and distal edges of the lesion;
- •stenosis ≥50% and \< 100%.
Exclusion Criteria
- •General exclusion criteria:
- •hemodynamic instability (including hypotension or use of vasopressors to maintain blood pressure);
- •STEMI, cardiopulmonary resuscitation, or cardiogenic shock within 7 days before surgery;
- •subjects were required to undergo planned PCI or CABG within 30 days after surgery, or had undergone PCI within 72 hours before surgery, or had undergone PCI within 30 days before surgery with a protocol-defined major adverse coronary event (MACE) or serious adverse event (SAE);
- •subjects had a stroke or transient ischemic attack (TIA) within 30 days before surgery;
- •subjects with active peptic ulcer or upper GI bleeding within 6 months before surgery;
- •The study lesion requires planned treatment with directional coronary atherectomy (DCA), laser, rotational atherectomy or any device except for balloon dilatation prior to stent placement
- •left ventricular ejection fraction (LVEF) \< 35%;
- •subjects with known allergies to or contraindications to antiplatelet drugs, anticoagulants, stent materials and their coatings, or allergies to contrast agents, unable to receive adequate preoperative medication or manage with clinically appropriate alternatives;
- •subjects had a history of bleeding tendency or coagulopathy or refused blood transfusion;
Outcomes
Primary Outcomes
Technical Success
Time Frame: Procedure
Defined as successful completion of the robotic-assisted PCI absent unplanned conversion to manual for guidewire or balloon/stent catheter inability to navigate vessel anatomy or poor guide catheter support.
Clinical Success
Time Frame: Discharge or 48 hours post intervention, whichever comes first
Less than 30% residual stenosis (visual estimate) post PCI in the lesion(s) treated with the Pan-vascular interventional robotic system, without in-hospital major adverse coronary events (MACE).
Secondary Outcomes
- Procedure Time(Procedure)
- PCI time(Procedure)
- Contrast agent dosage(Procedure)
- Fluoroscopy Time(Procedure)
- Radiation Exposure(Procedure)