CALM- 2 - Controlling and Lowering Blood Pressure With the MobiusHD™
The objective of this study is to evaluate the safety and effectiveness of the MobiusHD
System in a prospective, randomized, double-blind, sham-controlled multi-center pivotal
study. Patients with resistant hypertension who remain uncontrolled despite pharmacologic
treatment with maximum tolerated, guideline-directed anti-hypertensive pharmacologic therapy
will be evaluated.
Not recruiting | High Blood Pressure / Hypertension | Site Unknown
A Phase 3 Study to Compare the Efficacy and Safety of Humacyte's Human Acellular Vessel With That of an Autologous Arteriovenous Fistula in Subjects With End Stage Renal Disease
This is a Phase 3, prospective, multicenter, open-label, randomized, two-arm, comparative
study. Subjects who sign informed consent will undergo study-specific screening assessments
within 45 days from the day of informed consent.
Eligible study subjects will be randomized to receive either an HAV or AVF. The randomization
will be stratified by upper arm or forearm placement based on the investigator's
determination of where the study access (SA) should be located. Subjects will be followed to
24 months post SA creation at routine study visits regardless of patency status. After 24
months, AVF subjects with a patent SA will be followed (while the SA remains patent) for up
to 5 years (60 months) post SA creation at routine study visits. After 24 months, HAV
subjects will be followed (regardless of SA patency) for 5 years (60 months) post SA creation
at routine study visits.
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