A Clinical Study for the Pan-vascular Interventional Robotic System

NCT ID: NCT06110988

Last Updated: 2024-04-26

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 5 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-04-30
• Study Completion Date: 2024-09-30

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Pan-vascular interventional robotic system

Pan-vascular interventional robotic system assisted PCI

Group Type: EXPERIMENTAL

Pan-vascular interventional robotic system

Intervention Type: DEVICE

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

Interventions

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.

Intervention Type: DEVICE

Eligibility Criteria

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.

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. 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.

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).

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Shenzhen Institute of Advanced Biomedical Robot Co., Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Ge Junbo

Chief of Cardiology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Shanghai Zhongshan Hospital

Shanghai, Shanghai Municipality, China

Kashi Prefecture Second People's Hospital

Kashgar, Xinjiang, China

Countries

China

Central Contacts

Qingxing Chen, MD

Role: CONTACT

sunjiabao@abrobo.com

18999090210

Facility Contacts

Junbo Ge

Role: primary

sunjiabaojiayou@163.com

13764518896

Qingxing Chen, MD

Role: primary

kseyyxc@163.com

021-64041990

Other Identifiers

P02-IIT-KSI

Identifier Type: -

Identifier Source: org_study_id