SENTANTE: Fully Robotic Peripheral Endovascular Interventions

NCT ID: NCT06537947

Last Updated: 2025-05-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 10 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-07-19
• Study Completion Date: 2024-10-30

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DEVICE_FEASIBILITY
• Blinding Strategy: NONE

Study Groups

Endovascular interventions

Group Type: EXPERIMENTAL

Endovascular intervention using the SENTANTE endovascular robotic system

Intervention Type: 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.

Interventions

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.

Intervention Type: PROCEDURE

Eligibility Criteria

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.

• Minimum Eligible Age: 19 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

KCRI

OTHER

Sponsor Role: collaborator

SIA Kotello

UNKNOWN

Sponsor Role: collaborator

Syntropic Corelab

UNKNOWN

Sponsor Role: collaborator

Inovatyvi Medicina UAB

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Dainis Krievins, Prof PhD MD

Role: PRINCIPAL_INVESTIGATOR

Pauls Stradins Clinical University Hospital

Locations

Pauls Stradins Clinical university hospital

Riga, , Latvia

Countries

Latvia

Other Identifiers

CIV-24-05-047118

Identifier Type: OTHER

Identifier Source: secondary_id

24-SEN-002

Identifier Type: -

Identifier Source: org_study_id