SENTANTE: Fully Robotic Peripheral Endovascular Interventions

Inovatyvi Medicina UAB10 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

DEVICE_FEASIBILITY

Masking

NONE

Enrollment

Conditions

Any Disease Which Requires Peripheral Endovascular Intervention

Interventions

Eligibility

Sex: ALLMin age: 19 YearsMax age: 90 Years

Medical Language ↔ Plain English

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 ≥ 15. * Clinical condition that, in the opinion of the investigator, makes endovascular therapy impossible or hazardous. * Subject previously enrolled in this clinical trial. * Possible / probable non-compliance of subject with CIP required follow up or medication. * Subject is currently participating in another clinical trial that has not completed its primary endpoint assessment or would confound this Clinical Study. * Signs of SARS-CoV2 (COVID-19) active infection. * Patients with intervention-related anxiety, separation anxiety, autophobia and individuals that cannot be left alone without additional sedation or close supervision.

Outcomes

Primary Outcomes

Efficacy endpoint: Number of procedures with technical success

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.

Time frame: Immediately after intervention

Safety endpoint: Number of procedures without adverse device effects (ADEs)

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.

Time frame: Immediately after intervention and after 96 hours post procedure or hospital discharge if comes first

Secondary Outcomes

Procedural success: Number of procedures with achieved success

Procedure success is defined depending on the type of procedure as follows: i. Diagnostic procedure - sufficient diagnostic information was achieved to make further decisions on treatment plan. ii. Treatment of stenotic lesions / occlusions - \<50% residual stenosis in all SENTANTETM Robotic System treated lesions at the completion of the interventional procedure without an unplanned switch to the manual procedure in the absence of ADEs. iii. Treatment of bleeding or other diseases requiring embolization - successful occlusion of SENTANTETM robotic system treated vessels at the completion of the interventional procedure without an unplanned switch to the manual procedure in the absence of ADEs.

Time frame: Immediately after intervention and after 96 hours post procedure or hospital discharge if it comes first

Rate of manual assistance

Device manipulation requiring manual assistance during fluoroscopy, evaluated per procedure

Time frame: During the intervention

Rate of conversion to manual procedure

Performance of procedural steps manually instead of manipulation with a robotic system

Time frame: During the intervention

Successful advancement/retrieval of the device without manual assistance

The manipulation (advancement/retrieval) of endovascular devices with the SENTANTE robotic system will be evaluated per device basis

Time frame: During the intervention

Clinical success

Number of patients with confirmation that the performed intervention has achieved its intended therapeutic effect or clinical benefit

Time frame: Immediately after intervention and after 96 hours post procedure or hospital discharge if comes first

Safety level at access site

Number of patients without adverse events

Time frame: After 96 hours post procedure or before hospital discharge if it comes first

Radiation exposure in a typical operator workplace

Amount of radiation exposure while using robotic system

Time frame: Immediately after intervention

Procedural satisfaction reported by patients on dedicated form

Questionnaire to be completed by the patient after the intervention. Questionnaire consists of 8 questions. The response to each question is asked to be evaluated on a scale from 1 to 4, with 1 representing the favorable aspect of the characteristic described in the question and 4 representing the least favorable aspect of the characteristic described in the question.

Time frame: Within 96 hours post procedure or before hospital discharge if it comes first

Operator feedback on dedicated form

Questionnaire to be completed by the Operator after the intervention. Questionnaire consists of 10 questions. The response to each question is asked to be evaluated on a scale from 1 to 4, with 1 representing the favorable aspect of the characteristic described in the question and 4 representing the least favorable aspect of the characteristic described in the question.

Time frame: Within 96 hours post procedure

Nurse feedback on dedicated form

Questionnaire to be completed by the assisting personnel after the intervention. Questionnaire consists of 8 questions. The response to each question is asked to be evaluated on a scale from 1 to 4, with 1 representing the favorable aspect of the characteristic described in the question and 4 representing the least favorable aspect of the characteristic described in the question.

Time frame: 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

Recorded and reported clinical events

Time frame: Immediately after intervention and within 96 hours post procedure or before hospital discharge if it comes first

SENTANTE: Fully Robotic Peripheral Endovascular Interventions

Overview

Conditions

Interventions

Eligibility

Locations (1)

Outcomes

Primary Outcomes

Secondary Outcomes