Clinical trial NCT06537947: SENTANTE: Fully Robotic Peripheral Endovascular Interventions
Official title: A Single Center, First in Human Study to Evaluate the Feasibility of the SENTANTE Robotic System Application in Peripheral Endovascular Interventions
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Any Disease Which Requires Peripheral Endovascular Intervention
Keywords: robotic
endovascular
SENTANTE
robot
Lead sponsor: Inovatyvi Medicina UAB
Sponsor class: INDUSTRY
Collaborators: name: KCRI
name: SIA Kotello
name: Syntropic Corelab
First posted: 2024-08-05
Enrollment: 10
Sex: ALL
Minimum age (years): 19
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DEVICE_FEASIBILITY

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.


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.

Primary outcomes:
measure: Efficacy endpoint: Number of procedures with technical success
timeFrame: Immediately after intervention
measure: Safety endpoint: Number of procedures without adverse device effects (ADEs)
timeFrame: Immediately after intervention and after 96 hours post procedure or hospital discharge if comes first
Secondary outcomes:
measure: Procedural success: Number of procedures with achieved success
timeFrame: Immediately after intervention and after 96 hours post procedure or hospital discharge if it comes first
measure: Rate of manual assistance
timeFrame: During the intervention
measure: Rate of conversion to manual procedure
timeFrame: During the intervention
measure: Successful advancement/retrieval of the device without manual assistance
timeFrame: During the intervention
measure: Clinical success
timeFrame: Immediately after intervention and after 96 hours post procedure or hospital discharge if comes first
measure: Safety level at access site
timeFrame: After 96 hours post procedure or before hospital discharge if it comes first
measure: Radiation exposure in a typical operator workplace
timeFrame: Immediately after intervention
measure: Procedural satisfaction reported by patients on dedicated form
timeFrame: Within 96 hours post procedure or before hospital discharge if it comes first
measure: Operator feedback on dedicated form
timeFrame: Within 96 hours post procedure
measure: Nurse feedback on dedicated form
timeFrame: Within 96 hours post procedure
measure: Clinical events (adverse event (AE)/serious adverse event (SAE)/adverse device effect (ADE)) during the index procedure and till the discharge
timeFrame: Immediately after intervention and within 96 hours post procedure or before hospital discharge if it comes first
Other outcomes:
Locations:
city: Riga
country: Latvia
facility: Pauls Stradins Clinical university hospital
Study officials:
affiliation: Pauls Stradins Clinical University Hospital
name: Dainis Krievins, Prof PhD MD
role: PRINCIPAL_INVESTIGATOR
References: