Natural Vascular Scaffold (NVS) Therapy for Treatment of Atherosclerotic Lesions
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|ClinicalTrials.gov Identifier: NCT04188262|
Recruitment Status : Active, not recruiting
First Posted : December 5, 2019
Last Update Posted : March 23, 2021
|Condition or disease||Intervention/treatment||Phase|
|Peripheral Arterial Disease Peripheral Vascular Diseases Catheterization, Peripheral||Combination Product: NVS Therapy||Phase 1|
This is a prospective, non-randomized, multi-center, open label Phase 1 study to assess the safety, pharmacokinetics (PK), and preliminary efficacy trends to applying NVS therapy to de novo lesions in the superficial femoral artery (SFA) and the proximal popliteal artery (PPA) during percutaneous transluminal angioplasty (PTA) in patients with life-style limiting claudication due to obstructive SFA and proximal popliteal artery atherosclerosis. Each investigator will receive supervised training for each procedure.
Eligibility to participate in the study is determined during the screening period and prior to the index procedure with the NVS therapy. Study Data will be analyzed through the Day 365 follow-up visit.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||15 participants|
|Intervention Model:||Single Group Assignment|
|Intervention Model Description:||NVS Therapy will be delivered to de novo lesions in the superficial femoral artery (SFA) and proximal popliteal artery (PPA) during PTA in patients with symptomatic peripheral artery disease|
|Masking:||None (Open Label)|
|Official Title:||Natural Vascular Scaffolding (NVS) Therapy for the Treatment of Atherosclerotic Lesions in the Superficial Femoral Artery (SFA) and/or Proximal Popliteal Artery (PPA)|
|Actual Study Start Date :||May 22, 2020|
|Estimated Primary Completion Date :||August 2021|
|Estimated Study Completion Date :||August 2022|
Experimental: NVS Therapy
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.
Combination Product: NVS Therapy
Combination Product: NVS Therapy which includes NVS Injection (investigational product) and the following investigational devices: NVS Delivery Catheter, NVS light Fiber, and NVS light source.
Other Name: Natural Vascular Scaffold
- Freedom from all-cause mortality, freedom from target limb major amputation, freedom from target lesion revascularization (TLR). [ Time Frame: Day 30 ]The overall composite occurrence of participants free from all-cause mortality, target limb major amputation, target lesion revascularization (TLR) through post-index procedure Day 30 will be summarized as a percentage.
- NVS Drug Plasma Concentrations [ Time Frame: Day 1 - 24 (Or Discharge) ]The Peak Plasma Concentration (Cmax) will be determined from plasma 10-8-10 Dimer concentrations for blood samples collected.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04188262
|United States, Louisiana|
|Cardiovascular Institute of the South|
|Houma, Louisiana, United States, 70360|
|United States, Michigan|
|Mid-Michigan Heart & Vascular Center|
|Saginaw, Michigan, United States, 48604|
|United States, North Carolina|
|NC Heart & Vascular Research|
|Raleigh, North Carolina, United States, 27606|
|United States, Tennessee|
|Wellmont CVA Heart Institute|
|Kingsport, Tennessee, United States, 37660|
|Study Director:||Henry Hauser||Alucent Biomedical|