Natural Vascular Scaffold (NVS) Therapy for Treatment of Atherosclerotic Lesions (Activate I)

Study Overview
=================
Brief Summary
-----------------
The NVS Therapy is being studied to evaluate the safety and efficacy to facilitate retention of acute luminal gain, leading to acute hemodynamic improvement in superficial femoral and popliteal arteries with reference vessel diameters between 4.0 and 7.0 mm and lesion lengths less than or equal to 56mm.

Detailed Description
-----------------
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.

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)

Conditions
-----------------
Peripheral Arterial Disease, Peripheral Vascular Diseases, Catheterization, Peripheral

Intervention / Treatment
-----------------
* Combination Product: NVS Therapy


Participation Criteria
=================
Eligibility Criteria
-----------------
General Description of Subject Population: Adults with symptoms of claudication and/or rest pain (Rutherford Classification 2, 3, or 4) (see Appendix 3) and angiographic evidence of an atherosclerotic lesion of the superficial femoral artery and/or proximal popliteal artery ≥70% diameter stenosis and < 100% stenosis. Subjects must meet all of the following general eligibility criteria: Subject is at least 18 years of age. Subject (or legally authorized representative [LAR]) understands the study requirements and the treatment procedure and provides written informed consent before any study-specific tests or procedures are performed. Subject is eligible for PTA. Subject is willing to comply with all protocol required follow-up evaluations. Subject has documented Rutherford Classification 2 to 4 (see Appendix 3). Subject has laboratory test results that are within clinically acceptable limits. In investigator's opinion, subject is hemodynamically stable at the time of the index procedure. Subject has a life expectancy of ≥ 1 year in the opinion of the Investigator. Subject is able to tolerate the insertion of a 7F sheath into the common femoral artery (CFA), as determined by the investigator. Subject is able to undergo contralateral access, as determined by the Investigator. Exclusion Criteria: Subjects must not meet any of the following general eligibility criteria: Subject had cerebral vascular accident (CVA) or transient ischemic attack (TIA) within the past 3 months prior to enrollment with any residual deficit involving the index lower extremity. Subject has any permanent neurologic defect that may impair ambulation and/or cause non-compliance with the protocol. Subject had a STEMI or NSTEMI within the last 3 months prior to enrollment. Subject is pregnant, breastfeeding, or planning to become pregnant in the next 365 days. Subjects (male and female) must agree to use effective birth control measures for duration of study. Subject is currently receiving oral or intravenous immunosuppressive therapy (e.g., inhaled steroids are not excluded).

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Interventional 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)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: NVS Therapy<br>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<br>* 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.<br>* Other names: Natural Vascular Scaffold;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Freedom from all-cause mortality, freedom from target limb major amputation, freedom from target lesion revascularization (TLR). | 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. | Day 30 | 
| NVS Drug Plasma Concentrations | The Peak Plasma Concentration (Cmax) will be determined from plasma 10-8-10 Dimer concentrations for blood samples collected. | Day 1 - 24 (Or Discharge) |