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SENTANTE: Fully Robotic Peripheral Endovascular Interventions

NCT06537947 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 10

Last updated 2025-05-16

No results posted yet for this study

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

Interventions

PROCEDURE

Endovascular intervention using the SENTANTE endovascular robotic system

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.

Sponsors & Collaborators

  • KCRI

    collaborator OTHER

  • SIA Kotello

    collaborator UNKNOWN

  • Syntropic Corelab

    collaborator UNKNOWN

  • Inovatyvi Medicina UAB

    lead INDUSTRY

Principal Investigators

  • Dainis Krievins, Prof PhD MD · Pauls Stradins Clinical University Hospital

Study Design

Allocation
NA
Purpose
DEVICE_FEASIBILITY
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
19 Years
Max Age
90 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-07-19
Primary Completion
2024-10-30
Completion
2024-10-30

Countries

  • Latvia

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06537947 on ClinicalTrials.gov