Status:
COMPLETED
SENTANTE: Fully Robotic Peripheral Endovascular Interventions
Lead Sponsor:
Inovatyvi Medicina UAB
Collaborating Sponsors:
KCRI
SIA Kotello
Conditions:
Any Disease Which Requires Peripheral Endovascular Intervention
Eligibility:
All Genders
19-90 years
Phase:
NA
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 ...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
July 19 2024
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 30 2024
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT06537947
Start Date
July 19 2024
End Date
October 30 2024
Last Update
May 16 2025
Active Locations (1)
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1
Pauls Stradins Clinical university hospital
Riga, Latvia, LV-1002