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

NCT ID: NCT06502938

Last Updated: 2024-07-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

159 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-07-15

Study Completion Date

2025-12-15

Brief Summary

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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.

Detailed Description

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Conditions

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Percutaneous Coronary Intervention

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Pan-vascular interventional robotic system group

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.

Artificial control group

Traditional artificial percutaneous coronary intervention

Group Type EXPERIMENTAL

Traditional artificial percutaneous coronary intervention

Intervention Type PROCEDURE

Doctors perform traditional percutaneous coronary intervention

Interventions

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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

Traditional artificial percutaneous coronary intervention

Doctors perform traditional percutaneous coronary intervention

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

1. 18 years old ≤ age ≤85 years old;
2. have a clinical indication for PCI (clinical evidence of ischemic heart disease or a positive functional study);
3. 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.


1. The stenosis degree of visual target lesion ≥50%;
2. 2.5mm≤ Visual target vessel diameter ≤4.0mm;
3. Visual target lesions ≤38mm in length, or successive small lesions that can be completely covered by a single stent;
4. Target lesions to be treated intraoperatively cannot be treated in stages.
Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Shenzhen Institute of Advanced Biomedical Robot Co., Ltd.

INDUSTRY

Sponsor Role lead

Responsible Party

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Ge Junbo

Chief of Cardiology

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Beijing Anzhen Hospital,Capital Medical University

Beijing, Beijing Municipality, China

Site Status

The First Affiliated Hospital,Sun Yat-sen University

Guanzhou, Guandong, China

Site Status

Linfen Central Hospital

Shanxi, Linfen, China

Site Status

Shanghai Zhongshan Hospital

Shanghai, Shanghai Municipality, China

Site Status

The Affiliated Hospital of Hangzhou Normal University

Hangzhou, Zhejiang, China

Site Status

Countries

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China

Central Contacts

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Junbo Ge

Role: CONTACT

13767518896

Facility Contacts

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Hai Gao, MD

Role: primary

010-64412431

Xun Hu, MD

Role: primary

13631446306

Zhiming Shi

Role: primary

13753520432

Junbo Ge

Role: primary

13764518896

Peng Dong, MD

Role: primary

(0571)88303562

Other Identifiers

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CAPTAIN-C

Identifier Type: -

Identifier Source: org_study_id

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