A Clinical Study for the Pan-vascular Interventional Robotic System

NCT06110988 | Not Yet Recruiting

• 1 other identifier: P02-IIT-KSI
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 2

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.

Conditions

Percutaneous Coronary Intervention; Pan-vascular Interventional Robotic System

Outcome Measures

Primary Outcomes (2)

• Clinical Success

  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).

  Discharge or 48 hours post intervention, whichever comes first

• Technical Success

  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.

  Procedure

Secondary Outcomes (5)

• Procedure Time

  Procedure

• PCI time

  Procedure

• Fluoroscopy Time

  Procedure

• Radiation Exposure

  Procedure

• Contrast agent dosage

  Procedure

Study Arms (1)

Pan-vascular interventional robotic system

EXPERIMENTAL

Pan-vascular interventional robotic system assisted PCI

Device: Pan-vascular interventional robotic system

Interventions

Pan-vascular interventional robotic system DEVICE

Pan-vascular interventional robotic system assited PCI for delivery and manipulation of guidewires, catheters, and quick exchange balloon dilatation catheters/stents.

Pan-vascular interventional robotic system

Eligibility Criteria

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

You may qualify if:

• 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.
• 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%.

You may not qualify if:

• 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;
• severe liver and kidney dysfunction;
• patients who are scheduled to undergo additional cardiac surgery (e.g., valve replacement or cardiac ablation) within 30 days after surgery;
• inaccessible vascular access (radial artery/femoral artery) or severe vascular stenosis, occlusion or skin infection at the puncture site;
• uncontrolled severe infection;
• subjects participating in clinical studies of other devices or drugs during the same period;
• pregnant and lactating women of childbearing age;

Sponsors & Collaborators

• Shenzhen Institute of Advanced Biomedical Robot Co., Ltd.: lead

Study Sites (2)

Shanghai Zhongshan Hospital

Shanghai, Shanghai Municipality, 200000, China

Location

Kashi Prefecture Second People's Hospital

Kashgar, Xinjiang, China

Location

Central Study Contacts

Qingxing Chen, MD

CONTACT

18999090210; sunjiabao@abrobo.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief of Cardiology

Study Record Dates

• First Submitted: October 25, 2023
• First Posted: November 1, 2023
• Study Start: April 30, 2024
• Primary Completion: September 30, 2024
• Study Completion: September 30, 2024
• Last Updated: April 26, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (2)