SENTANTE: Fully Robotic Peripheral Endovascular Interventions

NCT06537947 | Completed

• 2 other identifiers: 24-SEN-002CIV-24-05-047118
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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.

Conditions

Any Disease Which Requires Peripheral Endovascular Intervention

Keywords

robotic; endovascular; SENTANTE; robot

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (11)

• Procedural success: Number of procedures with achieved success

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

• Rate of manual assistance

  During the intervention

• Rate of conversion to manual procedure

  During the intervention

• Successful advancement/retrieval of the device without manual assistance

  During the intervention

• Clinical success

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

Study Arms (1)

Endovascular interventions

EXPERIMENTAL

Procedure: Endovascular intervention using the SENTANTE endovascular robotic system

Interventions

Endovascular intervention using the SENTANTE endovascular robotic system PROCEDURE

1. Diagnostic procedure - placement of diagnostic catheter to intended vessel and performing angiography. 2. 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. 3. Coiling procedure - implantation of pushable coils or liquid embolization materials (such as microspheres) to an intended vessel.

Endovascular interventions

Eligibility Criteria

• Age: 19 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Inovatyvi Medicina UAB: lead
• KCRI: collaborator
• SIA Kotello: collaborator
• Syntropic Corelab: collaborator

Study Sites (1)

Pauls Stradins Clinical university hospital

Riga, LV-1002, Latvia

Location

Study Officials

• Dainis Krievins, Prof PhD MD

  Pauls Stradins Clinical University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DEVICE FEASIBILITY
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 29, 2024
• First Posted: August 5, 2024
• Study Start: July 19, 2024
• Primary Completion: October 30, 2024
• Study Completion: October 30, 2024
• Last Updated: May 16, 2025

Record last verified: 2025-05

Locations

LA (1)