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Vascular Scaffold
NVS Therapy for Peripheral Vascular Disease
Phase 1
Waitlist Available
Research Sponsored by Alucent Biomedical
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up day 1 - 24 (or discharge)
Awards & highlights
Study Summary
This trial is testing a new therapy to see if it is safe and effective at improving blood flow in the arteries of the leg.
Eligible Conditions
- Peripheral Vascular Disease
- Peripheral Arterial Disease
- Peripheral Catheterization
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ day 1 - 24 (or discharge)
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~day 1 - 24 (or discharge)
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Freedom from all-cause mortality, freedom from target limb major amputation, freedom from target lesion revascularization (TLR).
NVS Drug Plasma Concentrations
Trial Design
1Treatment groups
Experimental Treatment
Group I: NVS TherapyExperimental Treatment1 Intervention
NVS Therapy will be delivered to de novo lesions in Superficial Femoral Artery (SFA) and/or Proximal Popliteal Artery (PPA) during PTA in patients with symptomatic peripheral artery disease.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
NVS Therapy
2020
Completed Phase 1
~20
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Who is running the clinical trial?
Alucent BiomedicalLead Sponsor
4 Previous Clinical Trials
133 Total Patients Enrolled
Henry HauserStudy DirectorAlucent Biomedical
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