SENTANTE: Fully Robotic Peripheral Endovascular Interventions
NCT Number: NCT06537947
Acronym: ESSENTIAL
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Any Disease Which Requires Peripheral Endovascular Intervention
Interventions: PROCEDURE: Endovascular intervention using the SENTANTE endovascular robotic system
Sponsor: Inovatyvi Medicina UAB
Collaborators: KCRI|SIA Kotello|Syntropic Corelab
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 10
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: DEVICE_FEASIBILITY
Start Date: 2024-07-19
Completion Date: 2024-11-30
Locations: Pauls Stradins Clinical university hospital, Riga, LV-1002, Latvia

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.

Primary Outcome Measures: 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., 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., Immediately after intervention and after 96 hours post procedure or hospital discharge if comes first
Secondary Outcome Measures: 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., 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, During the intervention|Rate of conversion to manual procedure, Performance of procedural steps manually instead of manipulation with a robotic system, 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, During the intervention|Clinical success, Number of patients with confirmation that the performed intervention has achieved its intended therapeutic effect or clinical benefit, 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, 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, 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., 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., 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., 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, Immediately after intervention and within 96 hours post procedure or before hospital discharge if it comes first