A Clinical Trial Evaluating the Pan-vascular Interventional Robotic System for Panvascularization Interventional Surgery

NCT06502938 | Not Yet Recruiting

• 1 other identifier: CAPTAIN-C
• Study Type: interventional
• Target: 159
• Locations: 1 country
• Sites: 5

Brief Summary

The purpose of this prospective, randomized, open, parallel controlled, multicenter trial is to investigate the efficacy and safety of the pan-vascular interventional robotic system for percutaneous coronary intervention (PCI). Investigators will evaluate clinical success, technical success, and record intraoperative data (PCI time, total operating time, contrast agent dose, radiation exposure dose, etc.). All subjects were followed up on the day of surgery, before discharge and 1 month after surgery to observe the safety indicators.

Conditions

Percutaneous Coronary Intervention

Outcome Measures

Primary Outcomes (2)

• Clinical Success

  Immediate postoperative angiography showed residual stenosis \< 30% and TIMI blood flow fraction Level 3.

  Immediate postoperative angiography

• Clinical Success

  No MACE occurred in hospital.

  Discharge or 48 hours post intervention, whichever comes first

Secondary Outcomes (7)

• Technical success rate

  Procedure

• Radiation Exposure

  Procedure

• Fluoroscopy Time

  Procedure

• Contrast agent dosage

  Procedure

• Procedure Time

  Procedure

Study Arms (2)

Pan-vascular interventional robotic system group

EXPERIMENTAL

Pan-vascular interventional robotic system assisted PCI

Device: Pan-vascular interventional robotic system

Artificial control group

EXPERIMENTAL

Traditional artificial percutaneous coronary intervention

Procedure: Traditional artificial percutaneous coronary intervention

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 group

Traditional artificial percutaneous coronary intervention PROCEDURE

Doctors perform traditional percutaneous coronary intervention

Artificial control group

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• years old ≤ age ≤85 years old;
• have a clinical indication for PCI (clinical evidence of ischemic heart disease or a positive functional study);
• Subject or guardian can understand the purpose of the experiment and sign informed consent voluntarily Book and willing to cooperate to complete the follow-up.
• The stenosis degree of visual target lesion ≥50%;
• mm≤ Visual target vessel diameter ≤4.0mm;
• Visual target lesions ≤38mm in length, or successive small lesions that can be completely covered by a single stent;
• Target lesions to be treated intraoperatively cannot be treated in stages.

Sponsors & Collaborators

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

Study Sites (5)

Beijing Anzhen Hospital,Capital Medical University

Beijing, Beijing Municipality, 100000, China

Location

The First Affiliated Hospital,Sun Yat-sen University

Guanzhou, Guandong, 510080, China

Location

Linfen Central Hospital

Shanxi, Linfen, 041000, China

Location

Shanghai Zhongshan Hospital

Shanghai, Shanghai Municipality, 200000, China

Location

The Affiliated Hospital of Hangzhou Normal University

Hangzhou, Zhejiang, 310000, China

Location

Central Study Contacts

Junbo Ge

CONTACT

13767518896; sunjiabao@abrobo.com

Study Design

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

Study Record Dates

• First Submitted: July 9, 2024
• First Posted: July 16, 2024
• Study Start: July 15, 2024
• Primary Completion: July 15, 2025
• Study Completion: December 15, 2025
• Last Updated: July 16, 2024

Record last verified: 2024-07

Locations

CN (5)