SENTANTE: Fully Robotic Peripheral Endovascular Interventions (ESSENTIAL)

A Single Center, First in Human Study to Evaluate the Feasibility of the SENTANTE Robotic System Application in Peripheral Endovascular Interventions

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 Overview

• Status: Completed
• Conditions: Any Disease Which Requires Peripheral Endovascular Intervention
• Intervention / Treatment: Procedure: Endovascular intervention using the SENTANTE endovascular robotic system

• Study Type: Interventional
• Enrollment (Actual): 10
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Latvia
  • Riga, Latvia, LV-1002
    • Pauls Stradins Clinical University hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Device Feasibility
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Endovascular interventions

Procedure: Endovascular intervention using the SENTANTE endovascular robotic system; Diagnostic procedure - placement of diagnostic catheter to intended vessel and performing angiography.; Percutaneous transluminal angioplasty (PTA)/stenting procedure - placement of balloon catheter or balloon expandable stent to intended vessel and effectively expanding it up to nominal pressure.; Coiling procedure - implantation of pushable coils or liquid embolization materials (such as microspheres) to an intended vessel.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Inovatyvi Medicina UAB
• Collaborators: KCRI; Syntropic Corelab; SIA Kotello
• Investigators: Principal Investigator: Dainis Krievins, Prof PhD MD, Pauls Stradins Clinical University hospital

Study record dates

Study Major Dates

• Study Start (Actual): July 19, 2024
• Primary Completion (Actual): October 30, 2024
• Study Completion (Actual): October 30, 2024

Study Registration Dates

• First Submitted: July 29, 2024
• First Submitted That Met QC Criteria: August 2, 2024
• First Posted (Actual): August 5, 2024

Study Record Updates

• Last Update Posted (Actual): May 16, 2025
• Last Update Submitted That Met QC Criteria: May 13, 2025
• Last Verified: May 1, 2025

More Information

Terms related to this study

• Keywords: endovascular; robotic; robot; SENTANTE
• Other Study ID Numbers: 24-SEN-002; CIV-24-05-047118 (Other Identifier: EUDAMED)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No