Safety and Effectiveness Clinical Study of Novelrad Vascular Closure System (NVCS)
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorNovelrad Ltd.
About this trial
This study evaluates the safety and effectiveness of the Novelrad Vascular Closure System (NVCS), a suture-mediated vascular closure system, in achieving post-procedure hemostasis in subjects undergoing interventional catheterization procedures through the common femoral artery using large-bore procedural sheaths.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Subject is ≥18 years old.
Subject is scheduled for elective or planned (i.e., not emergent or urgent) percutaneous transcatheter interventional procedures involving access through the common femoral artery using 8-22 French introducer sheaths such as TAVI/TAVR/EVAR/TEVAR etc.
Subject has common femoral artery diameter ≥ 6 mm and accepted calcification status as evaluated on pre-procedural CT angiography by the investigator and by the Sponsor, if requested.
Subject is able to undergo emergent vascular surgery if a complication related to the vascular closure necessitates such surgery.
Disqualifiers
Known to be pregnant or lactating.
Immunocompromised or with pre-existing autoimmune disease.
Systemic infection or a local infection at or near the access site.
Significant anemia (Hgb < 9 g/dL hematocrit <30%).
Trial design
Design model
Single group
Treatments tested in this trial
Novelrad Vascular Closure System (NVCS)
DeviceNVCS will be used to close the common femoral artery access site while reducing time-to-hemostasis in subjects who have undergone diagnostic or interventional catheterization procedures using 8-22 French (F) Sheaths.
Treatment groups
65 Participants
are divided into 1 treatment groupGroup A: Novelrad Vascular Closure System (NVCS)Experimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Safety: Freedom from major complications of the target limb within 30 days following the NVCS and index procedure.
Assessment of the incidence of protocol defined major complications of the target limb access site through 30 days post NVCS and index procedure as specified in the protocol.
Time frame
Within 30 days post-procedure2
Effectiveness: Time to Hemostasis
TTH is defined as the time elapsed from procedural sheath removal to first observed cessation of common femoral artery bleeding (excluding cutaneous or subcutaneous oozing at access site).
Time frame
PeriproceduralSecondary outcomes
1
Safety: Freedom from minor complications at the target limb access site
Assessment of the incidence of minor complications of the target limb access site as specified in the protocol.
Time frame
Within 30 days post procedure2
Effectiveness: Technical Success
Defined as achievement of hemostasis with the NVCS without the use of unplanned endovascular or surgical intervention
Time frame
Periprocedural3
Effectiveness: Treatment Success
Defined as technical success and freedom from major complications through 30 days follow-up
Time frame
Within 30 days post procedure4
Effectiveness: Time to Ambulation
Defined as the elapsed time between last procedural sheath removal and when ambulation is achieved (subject is standing and walking at least 6-meters without bleeding).
Time frame
At least 6 hours after sheath removalLocations
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov
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