Percutaneous Coronary InterventionNCT06502938
A Clinical Trial Evaluating the Pan-vascular Interventional Robotic System for Panvascularization Interventional Surgery
A study testing Pan-vascular interventional robotic system and Traditional artificial percutaneous coronary intervention in people with Percutaneous Coronary Intervention, run by Shenzhen Institute of Advanced Biomedical Robot Co., Ltd. at 5 sites in China.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Percutaneous Coronary Intervention
- What is being tested?
- Pan-vascular interventional robotic system and Traditional artificial percutaneous coronary intervention
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 159 participants
- Where
- 5 sitesChina
- Study dates
- 15 Jul 2024to 15 Dec 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 1. General Inclusion criteria:
- 18 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.
- 2. Angiographic inclusion criteria:
- The stenosis degree of visual target lesion ≥50%;
Show all 9Show fewer
- 2.5mm≤ 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.
Who cannot join
- General exclusion criteria 1)A stroke occurred within 30 days prior to surgery; 2)Percutaneous coronary intervention was performed within 72 hours before surgery; 3)Acute myocardial infarction, cardiogenic shock, or infarction occurred within 48 hours before surgery Received CPR; 4)Other cardiac procedures (such as aortic valve placement) are scheduled within 30 days of surgery Coronary artery bypass grafting, etc.); 5)Pregnant or lactating female subjects; 6)Severe hepatic or renal insufficiency or bleeding tendency; 7)Known allergy to interventional device materials and their coatings, or allergy to contrast agents; 8)Severe stenosis, occlusion of blood vessels at the intended puncture site, or local skin infection and uncontrollable; 9)Are participating in other interventional clinical studies, and have not completed the evaluation of the primary endpoint of the relevant study; 10)Participants who had other contraindications for interventional therapy or were judged by the investigator to be unsuitable for participation in the study;
- Angiographic exclusion criteria 1)The TIMI blood flow grade of the target lesion was < 2; 2)Treatment requiring intrastent restenosis, or prior placement of a stent in the target vessel near both ends of the target lesion; 3)Severe tortuosity or severe calcification of blood vessels; 4)There's an intracavitary thrombus; 5)In addition to balloon forming and stent implantation, other treatments (such as atheromatectomy, rotary grinding, laser ablation, etc.) are also required at the same time; 6)The researchers determined that percutaneous coronary intervention was not suitable for robotic assistance or that there might be high risks in the process.
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
China5 sites
Beijing Anzhen Hospital,Capital Medical University
Beijing, Beijing Municipality, 100000
Hai Gao, MD, 010-64412431
The First Affiliated Hospital,Sun Yat-sen University
Guanzhou, Guandong, 510080
Xun Hu, MD, 13631446306
The Affiliated Hospital of Hangzhou Normal University
Hangzhou, Zhejiang, 310000
Peng Dong, MD, （0571）88303562
Shanghai Zhongshan Hospital
Shanghai, Shanghai Municipality, 200000
Junbo Ge, 13764518896, sunjiabaojiayou@163.com
Linfen Central Hospital
Shanxi, Linfen, 041000
Zhiming Shi, 13753520432, 315973663@qq.com
About this study
Official title: To Evaluate Percutaneous Coronary Intervention Assisted by the Control System of Panvascular Interventional Surgery Efficacy and Safety Clinical Trials
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
- Being tested
- Pan-vascular interventional robotic system, Traditional artificial percutaneous coronary intervention
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pan-vascular interventional robotic systemDevice
Pan-vascular interventional robotic system assited PCI for delivery and manipulation of guidewires, catheters, and quick exchange balloon dilatation catheters/stents.
Traditional artificial percutaneous coronary interventionProcedure or surgery
Doctors perform traditional percutaneous coronary intervention
| Study group | Role | What they receive |
|---|---|---|
| Pan-vascular interventional robotic system group | Experimental | Pan-vascular interventional robotic system assisted PCI Receives: Device: Pan-vascular interventional robotic system |
| Artificial control group | Experimental | Traditional artificial percutaneous coronary intervention Receives: Procedure: Traditional artificial percutaneous coronary intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical Success
Immediate postoperative angiography showed residual stenosis < 30% and TIMI blood flow fraction Level 3.
Measured: Immediate postoperative angiography
Clinical Success
No MACE occurred in hospital.
Measured: Discharge or 48 hours post intervention, whichever comes first
Secondary outcomes (7)
Technical success rate
- PCI was assisted by the Pan-vascular Interventional Robotic System.
- No unplanned complete conversion to artificial surgery occurred due to the inability to complete the delivery of the guide wire or balloon/stent catheter through the vessel with the test instrument as intended, or due to insufficient guide catheter support.
Measured: Procedure
Radiation Exposure
Patient and Main operator radiation exposure dose recorded by portable radiation
Measured: Procedure
Fluoroscopy Time
Total Fluoroscopy Time during procedure will be captured.
Measured: Procedure
Contrast agent dosage
The total amount of contrast agent used during the whole procedure.
Measured: Procedure
Procedure Time
Defined as the time measured from the insertion of the hemostasis sheath until the removal of the guide catheter.
Measured: Procedure
PCI time
Defined as the time measured from the insertion of the guide catheter until the removal of the guide catheter.
Measured: Procedure
the Pan-vascular Interventional Robotic Systemt performance evaluation
The performance of the product was subjectively evaluated by the surgeon.
Measured: After the operation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jul 2024
- Study start15 Jul 2024 (estimated)
- Primary completion15 Jul 2025 (estimated)
- Study completion15 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Percutaneous Coronary InterventionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 159 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shenzhen Institute of Advanced Biomedical Robot Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Principal investigator, Ge Junbo, Shanghai Zhongshan Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06502938
- Sponsor's protocol ID
- CAPTAIN-C
- Status last verified
- Jul 2024
- First submitted
- 9 Jul 2024
- Last updated
- 16 Jul 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- To Evaluate Percutaneous Coronary Intervention Assisted by the Control System of Panvascular Interventional Surgery Efficacy and Safety Clinical Trials
- ClinicalTrials.gov ID
- NCT06502938
- Acronym / sponsor ID
- CAPTAIN-C
- Conditions
- Percutaneous Coronary Intervention
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 159 participants (estimated)
- Lead sponsor
- Shenzhen Institute of Advanced Biomedical Robot Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 15 Jul 2024 (estimated)
- Primary completion
- 15 Jul 2025 (estimated)
- Study completion
- 15 Dec 2025 (estimated)
- First posted
- 16 Jul 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pan-vascular interventional robotic system group | Experimental | Device: Pan-vascular interventional robotic systemPan-vascular interventional robotic system assisted PCI |
| Artificial control group | Experimental | Procedure: Traditional artificial percutaneous coronary interventionTraditional artificial percutaneous coronary intervention |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 18 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%;
- 2.5mm≤ Visual target vessel diameter ≤4.0mm;
Key exclusion criteria (2 listed)
- General exclusion criteria 1)A stroke occurred within 30 days prior to surgery; 2)Percutaneous coronary intervention was performed within 72 hours before surgery; 3)Acute myocardial infarction, cardiogenic shock, or infarction occurred within 48 hours before surgery Received CPR; 4)Other cardiac procedures (such as aortic valve placement) are scheduled within 30 days of surgery Coronary artery bypass grafting, etc.); 5)Pregnant or lactating female subjects; 6)Severe hepatic or renal insufficiency or bleeding tendency; 7)Known allergy to interventional device materials and their coatings, or allergy to contrast agents; 8)Severe stenosis, occlusion of blood vessels at the intended puncture site, or local skin infection and uncontrollable; 9)Are participating in other interventional clinical studies, and have not completed the evaluation of the primary endpoint of the relevant study; 10)Participants who had other contraindications for interventional therapy or were judged by the investigator to be unsuitable for participation in the study;
- Angiographic exclusion criteria 1)The TIMI blood flow grade of the target lesion was < 2; 2)Treatment requiring intrastent restenosis, or prior placement of a stent in the target vessel near both ends of the target lesion; 3)Severe tortuosity or severe calcification of blood vessels; 4)There's an intracavitary thrombus; 5)In addition to balloon forming and stent implantation, other treatments (such as atheromatectomy, rotary grinding, laser ablation, etc.) are also required at the same time; 6)The researchers determined that percutaneous coronary intervention was not suitable for robotic assistance or that there might be high risks in the process.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pan-vascular interventional robotic systemPan-vascular interventional robotic system assited PCI for delivery and manipulation of guidewires, catheters, and quick exchange balloon dilatation catheters/stents. | Device | Pan-vascular interventional robotic system group |
| Traditional artificial percutaneous coronary interventionDoctors perform traditional percutaneous coronary intervention | Procedure or surgery | Artificial control group |
Primary outcome
Clinical Success
Time frame: Immediate postoperative angiography
Immediate postoperative angiography showed residual stenosis < 30% and TIMI blood flow fraction Level 3.
Clinical Success
Time frame: Discharge or 48 hours post intervention, whichever comes first
No MACE occurred in hospital.
7 secondary outcomes
Technical success rate
Time frame: Procedure
Radiation Exposure
Time frame: Procedure
Fluoroscopy Time
Time frame: Procedure
Contrast agent dosage
Time frame: Procedure
Procedure Time
Time frame: Procedure
PCI time
Time frame: Procedure
the Pan-vascular Interventional Robotic Systemt performance evaluation
Time frame: After the operation
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jul 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pan-vascular interventional robotic system and Traditional artificial percutaneous coronary intervention in people with Percutaneous Coronary Intervention, run by Shenzhen Institute of Advanced Biomedical Robot Co., Ltd. at 5 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 16 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Junbo Ge (13767518896, sunjiabao@abrobo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical Success (time frame: Immediate postoperative angiography). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jul 2024.