Any Disease Which Requires Peripheral Endovascular InterventionESSENTIALNCT06537947

SENTANTE: Fully Robotic Peripheral Endovascular Interventions

A study testing Endovascular intervention using the SENTANTE endovascular robotic system in people with Any Disease Which Requires Peripheral Endovascular Intervention, run by Inovatyvi Medicina UAB at 1 site in Latvia.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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. Read more about this study

Who is it for?: Ages 19 to 90 years
Conditions the study is for: Any Disease Which Requires Peripheral Endovascular Intervention
What is being tested?: Endovascular intervention using the SENTANTE endovascular robotic system
Type of treatment: Surgery or procedure
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 10 participants
Where: 1 siteLatvia
Study dates: 19 Jul 2024to 30 Oct 2024
Phase: Interventional
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 19 to 90 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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.

Who cannot join

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.

Show all 15Show fewer

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.

Trial locations and contacts

1 site in 1 country.

Latvia1 site

Pauls Stradins Clinical university hospital
Riga, LV-1002

Other trials in Latvia

About this study

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

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
Being tested: Endovascular intervention using the SENTANTE endovascular robotic system
Keywords: robotic, endovascular, SENTANTE, robot

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Endovascular intervention using the SENTANTE endovascular robotic systemProcedure or surgery
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.

Study groups in NCT06537947
Study group	Role	What they receive
Endovascular interventions	Experimental	Not described Receives: Procedure: Endovascular intervention using the SENTANTE endovascular robotic system

What is being measured

The primary outcome is the main question the study is designed to answer.

Efficacy endpoint: Number of procedures with technical success
Technical success rate counted per procedure basis, defined as:
1. 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.
Measured: 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:
1. 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.
Measured: 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
Procedure success is defined depending on the type of procedure as follows:
1. 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.
Measured: 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
Measured: During the intervention
Rate of conversion to manual procedure
Performance of procedural steps manually instead of manipulation with a robotic system
Measured: 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
Measured: During the intervention
Clinical success
Number of patients with confirmation that the performed intervention has achieved its intended therapeutic effect or clinical benefit
Measured: 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
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: Immediately after intervention and within 96 hours post procedure or before hospital discharge if it comes first

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

19 Jul 202430 Oct 2024

First posted5 Aug 2024
Study start19 Jul 2024
Primary completion30 Oct 2024
Study completion30 Oct 2024

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Any Disease Which Requires Peripheral Endovascular InterventionStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Device feasibility
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 10 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT06537947
Sponsor's protocol ID: 24-SEN-002
Other IDs: CIV-24-05-047118
Acronym: ESSENTIAL
Status last verified: May 2025
First submitted: 29 Jul 2024
Last updated: 16 May 2025
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No

Study at a glance

From the registry record, last updated by the sponsor on 16 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Single Center, First in Human Study to Evaluate the Feasibility of the SENTANTE Robotic System Application in Peripheral Endovascular Interventions
ClinicalTrials.gov ID: NCT06537947
Acronym / sponsor ID: ESSENTIAL / 24-SEN-002
Conditions: Any Disease Which Requires Peripheral Endovascular Intervention
Keywords: robotic, endovascular, SENTANTE, robot
Study type: Interventional
Recruitment status: Completed
Enrolment: 10 participants (actual)
Lead sponsor: Inovatyvi Medicina UABIndustry (pharma, biotech, devices)
Collaborators: KCRI, SIA Kotello, Syntropic Corelab
Study start: 19 Jul 2024 (actual)
Primary completion: 30 Oct 2024 (actual)
Study completion: 30 Oct 2024 (actual)
First posted: 5 Aug 2024 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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 design

Primary purpose: Device feasibility
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Endovascular interventions	Experimental	Procedure: Endovascular intervention using the SENTANTE endovascular robotic system

Who may qualify

Ages: 19 to 90 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (5 listed)

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.

Key exclusion criteria (15 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Endovascular intervention using the SENTANTE endovascular robotic system1. 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.	Procedure or surgery	Endovascular interventions

Primary outcome

Efficacy endpoint: Number of procedures with technical success
Time frame: Immediately after intervention
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.
Safety endpoint: Number of procedures without adverse device effects (ADEs)
Time frame: Immediately after intervention and after 96 hours post procedure or hospital discharge if comes first
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.

11 secondary outcomes

Procedural success: Number of procedures with achieved success
Time frame: Immediately after intervention and after 96 hours post procedure or hospital discharge if it comes first
Rate of manual assistance
Time frame: During the intervention
Rate of conversion to manual procedure
Time frame: During the intervention
Successful advancement/retrieval of the device without manual assistance
Time frame: During the intervention
Clinical success
Time frame: Immediately after intervention and after 96 hours post procedure or hospital discharge if comes first
Safety level at access site
Time frame: After 96 hours post procedure or before hospital discharge if it comes first
Radiation exposure in a typical operator workplace
Time frame: Immediately after intervention
Procedural satisfaction reported by patients on dedicated form
Time frame: Within 96 hours post procedure or before hospital discharge if it comes first
Operator feedback on dedicated form
Time frame: Within 96 hours post procedure
Nurse feedback on dedicated form
Time frame: 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
Time frame: Immediately after intervention and within 96 hours post procedure or before hospital discharge if it comes first

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 16 May 2025.

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Dainis Krievins, Prof PhD MD principal investigator

Pauls Stradins Clinical University Hospital

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 16 May 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Latvia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Efficacy endpoint: Number of procedures with technical success (time frame: Immediately after intervention). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06537947.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 May 2025.