A Single Center, First in Human Study to Evaluate the Feasibility of the SENTANTE Robotic System Application in Peripheral Endovascular Interventions
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Any Disease Which Requires Peripheral Endovascular Intervention
- Sponsor
- Inovatyvi Medicina UAB
- Enrollment
- 10
- Locations
- 1
- Primary Endpoint
- Safety endpoint: Number of procedures without adverse device effects (ADEs)
- Status
- Completed
- Last Updated
- 11 months ago
Overview
Brief Summary
The objective of the study is to evaluate the feasibility, safety and initial efficacy of the clinical and technical performance of the SENTANTE robotic system in the remote delivery and manipulation of commonly used and compatible guidewires and catheter-based devices for use in peripheral endovascular procedures.
The study will be a single-center, prospective investigation, designed to evaluate the safety, feasibility, and initial efficacy of robotic system for remote endovascular interventions in adults with disease which requires peripheral endovascular treatment with compatible devices. Participants meeting the inclusion criteria will undergo endovascular interventions using SENTANTE robotic system. Data will be collected through clinical assessments, imaging and other studies, laboratory tests, and feedback from medical personnel and patients.
The study will adhere to ethical guidelines, obtain informed consent from all participants, and be conducted under the oversight of the Clinical Events Committee.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Subject is ≥ 19 years and ≤ 90 years of age.
- •Subject is willing and able to provide appropriate study-specific informed consent and follow Clinical Investigation Plan (CIP) procedures.
- •Life expectancy ≥ 12 months from the date of the index procedure.
- •Females who are not pregnant or lactating and not planning to become pregnant for the duration of the study.
- •Subject is diagnosed with a disease which requires peripheral endovascular intervention using compatible with SENTANTE guidewires and catheter-based devices.
Exclusion Criteria
- •Planned interventional procedure or surgery of the carotid, coronary or peripheral arteries within 30 days before or after the index procedure.
- •Subjects with myocardial infarct or cerebrovascular event within 3 months prior to index procedure.
- •Severe vascular anatomy that would preclude safe sheath insertion, or deliverability of stent.
- •History of bleeding diathesis or coagulopathy.
- •History of thrombophilia.
- •Sensitivity to contrast media that cannot be adequately pre-treated.
- •Sensitivity to both forms of CIP-acceptable anticoagulation strategies (i.e., both heparin AND Bivalirudin).
- •Sensitivity to an antiplatelet agent AND all CIP acceptable alternative antiplatelet options.
- •Major neurologic deficit with NIHSS of ≥
- •Clinical condition that, in the opinion of the investigator, makes endovascular therapy impossible or hazardous.
Outcomes
Primary Outcomes
Safety endpoint: Number of procedures without adverse device effects (ADEs)
Time Frame: Immediately after intervention and after 96 hours post procedure or hospital discharge if comes first
Safety level counted per procedure basis, defined as absence of evidence of device related clinically significant vessel injury, with particular emphasis on events such as: i. Perforation, ii. Thrombosis, iii. Flow limiting residual dissection, iv. Distal embolization (excluding embolization procedure). The assessment of the impact of observed ADEs on the safety profile of the robotic system will be based on the Clinical event committee (CEC) adjudication.
Efficacy endpoint: Number of procedures with technical success
Time Frame: Immediately after intervention
Technical success rate counted per procedure basis, defined as: i. Diagnostic procedure - placement of diagnostic catheter to intended vessel and performing angiography. ii. PTA/stenting procedure - placement of balloon catheter or balloon expandable stent to intended vessel and effectively expanding it up to nominal pressure. iii. Coiling procedure - implantation of pushable coils or liquid embolization materials (such as microspheres) to an intended vessel.
Secondary Outcomes
- Rate of conversion to manual procedure(During the intervention)
- Nurse feedback on dedicated form(Within 96 hours post procedure)
- Successful advancement/retrieval of the device without manual assistance(During the intervention)
- Rate of manual assistance(During the intervention)
- Clinical success(Immediately after intervention and after 96 hours post procedure or hospital discharge if comes first)
- Radiation exposure in a typical operator workplace(Immediately after intervention)
- Procedural satisfaction reported by patients on dedicated form(Within 96 hours post procedure or before hospital discharge if it comes first)
- Procedural success: Number of procedures with achieved success(Immediately after intervention and after 96 hours post procedure or hospital discharge if it comes first)
- Safety level at access site(After 96 hours post procedure or before hospital discharge if it comes first)
- Operator feedback on dedicated form(Within 96 hours post procedure)
- Clinical events (adverse event (AE)/serious adverse event (SAE)/adverse device effect (ADE)) during the index procedure and till the discharge(Immediately after intervention and within 96 hours post procedure or before hospital discharge if it comes first)