A Clinical Study for the Pan-vascular Interventional Robotic System

A Clinical Study for Pan-vascular Interventional Control System in Percutaneous Coronary Intervention

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Percutaneous Coronary Intervention; Pan-vascular Interventional Robotic System
• Intervention / Treatment: Device: Pan-vascular interventional robotic system

• Study Type: Interventional
• Enrollment (Estimated): 5
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Qingxing Chen, MD; Phone Number: 18999090210; Email: sunjiabao@abrobo.com

Study Locations

• China
  • Shanghai
    • Shanghai, Shanghai, China, 200000
      • Shanghai Zhongshan Hospital
      • Contact: Junbo Ge; Phone Number: 13764518896; Email: sunjiabaojiayou@163.com
  • Xinjiang
    • Kashgar, Xinjiang, China
      • Kashi Prefecture Second People's Hospital
      • Contact: Qingxing Chen, MD; Phone Number: 021-64041990; Email: kseyyxc@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. General Inclusion criteria:

1. 18 years old ≤ age ≤80 years old;
2. have a clinical indication for PCI (clinical evidence of ischemic heart disease or a positive functional study);
3. 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.

2. Angiographic inclusion criteria:

1. study lesion is a single de novo native coronary artery lesion (previously untreated coronary artery disease);
2. target vessel diameter between 2.5 mm and 4.0 mm;
3. single lesion length ≤38 mm, with at least 2.0 mm normal segments on the proximal and distal edges of the lesion;
4. stenosis ≥50% and < 100%.

Exclusion Criteria:

1. General exclusion criteria:

1. hemodynamic instability (including hypotension or use of vasopressors to maintain blood pressure);
2. STEMI, cardiopulmonary resuscitation, or cardiogenic shock within 7 days before surgery;
3. 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);
4. subjects had a stroke or transient ischemic attack (TIA) within 30 days before surgery;
5. subjects with active peptic ulcer or upper GI bleeding within 6 months before surgery;
6. 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
7. left ventricular ejection fraction (LVEF) < 35%;
8. 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;
9. subjects had a history of bleeding tendency or coagulopathy or refused blood transfusion;
10. severe liver and kidney dysfunction;
11. patients who are scheduled to undergo additional cardiac surgery (e.g., valve replacement or cardiac ablation) within 30 days after surgery;
12. inaccessible vascular access (radial artery/femoral artery) or severe vascular stenosis, occlusion or skin infection at the puncture site;
13. uncontrolled severe infection;
14. subjects participating in clinical studies of other devices or drugs during the same period;
15. pregnant and lactating women of childbearing age;
16. subjects judged by the investigator to be ineligible for the study.

2. Exclusion criteria for angiography:

1. in-stent restenosis or any previous stent placement within 5.0 mm (proximal or distal) of the target lesion；
2. bifurcation lesions, in which the target vessel branch needs to be protected but cannot be protected;
3. the target lesion is located at the ostium or anastomosis of coronary artery;
4. investigate evidence of intravascular thrombosis;
5. severe tortuosity or calcification of the proximal end of the study vessel or target lesion;
6. study the complete occlusion of the lesion;
7. Target lesion located in left main coronary artery, or unprotected left main coronary artery disease (> 50% stenosis in left main coronary artery).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Pan-vascular interventional robotic system; Pan-vascular interventional robotic system assisted PCI	Device: Pan-vascular interventional robotic system; Pan-vascular interventional robotic system assited PCI for delivery and manipulation of guidewires, catheters, and quick exchange balloon dilatation catheters/stents.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Procedure Time	Defined as the time measured from the insertion of the hemostasis sheath until the removal of the guide catheter.	Procedure
PCI time	Defined as the time measured from the insertion of the guide catheter until the removal of the guide catheter.	Procedure
Fluoroscopy Time	Total Fluoroscopy Time during procedure will be captured	Procedure
Radiation Exposure	Patient and Main operator radiation exposure dose recorded by portable radiation monitor during the procedure, respectively.	Procedure
Contrast agent dosage	The total amount of contrast agent used during the whole procedure.	Procedure

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (Estimated): April 30, 2024
• Primary Completion (Estimated): September 30, 2024
• Study Completion (Estimated): September 30, 2024

Study Registration Dates

• First Submitted: October 25, 2023
• First Submitted That Met QC Criteria: October 30, 2023
• First Posted (Actual): November 1, 2023

Study Record Updates

• Last Update Posted (Actual): April 26, 2024
• Last Update Submitted That Met QC Criteria: April 25, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: P02-IIT-KSI

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No