Natural Vascular Scaffold (NVS) Therapy

NCT03148808 | Completed Phase 1 DMC FDA Drug FDA Device

• 1 other identifier: Protocol No.: 1060-001
• Study Type: interventional
• Target: 3
• Locations: 1 country
• Sites: 3

Brief Summary

The NVS Therapy is being studied to evaluate the safety and efficacy of retention of acute luminal gain, leading to acute hemodynamic improvement in superficial femoral and popliteal arteries with reference vessel diameters between 3.5 and 7.0 mm and lesion lengths between 36 and 96mm. The system is intended for use in patients with de novo lesions in the superficial femoral and proximal popliteal arteries.

Conditions

Peripheral Arterial Disease; Peripheral Vascular Diseases; Catheterization, Peripheral

Outcome Measures

Primary Outcomes (1)

• Freedom from all-cause mortality, target limb major amputation, and target lesion revascularization based on clinical observations

  The overall composite occurrence of participants free from from all-cause mortality, target limb major amputation, and target lesion revascularization through post-index procedure to Day 30 will be summarized as a percentage.

  Day 30

Other Outcomes (1)

• NVS Drug Plasma Concentrations

  Day 1

Study Arms (1)

NVS Therapy

EXPERIMENTAL

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.

Combination Product: NVS Therapy

Interventions

NVS Therapy COMBINATION_PRODUCT

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.

Also known as: Natural Vascular Scaffold Therapy

NVS Therapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subject is at least 18 years of age.
• Subject (or legal guardian) 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.

You may not qualify if:

• Subject had cerebrovascular accident (CVA) or transient ischemic attack (TIA) within the past 3 months prior to enrollment.
• Subject has any permanent neurologic defect that may cause non-compliance with the protocol.
• Subject had an MI within last the 3 months prior to enrollment.
• Subject is pregnant, planning to become pregnant, breastfeeding or planning to breastfeed in the next 365 days.
• Subject is currently receiving oral or intravenous immunosuppressive therapy (ie, inhaled steroids are not excluded).
• Subject has known life-limiting immunosuppressive or autoimmune disease (eg, human immunodeficiency virus, systemic lupus erythematosus, but not including diabetes mellitus).
• Subject has local or systemic thrombolytic therapy within 48 hours prior to index procedure.
• Subject is currently on oral anticoagulation therapy, such as warfarin, rivaroxaban, apixaban, or dabigatran etexilate.
• Subject has known allergies or sensitivities to heparin, aspirin (ASA), or other anticoagulant/antiplatelet therapies.
• Subject has an allergy to contrast media that cannot be adequately pre-treated prior to the index procedure.
• Subject has an active peptic ulcer or active gastrointestinal (GI) bleeding.
• Subject has documented or suspected liver disease, including laboratory evidence of hepatitis.
• Subject has renal failure or chronic kidney disease with glomerular filtration rate (GFR) ≤ 30 mL/min or Modification of Diet in Renal Disease (MDRD) study equation result of ≤ 30 mL/min per 1.73 m2.
• Subject has white blood cell (WBC) count \< (3,000 cells/mm3) within 7 days prior to index procedure.
• Subject has a platelet count \< 100,000 cells/mm3 or \> 700,000 cells/mm3 ≤ 7 days pre-procedure.

Sponsors & Collaborators

• Alucent Biomedical: lead

Study Sites (3)

OhioHealth Research Institute

Columbus, Ohio, 43214, United States

Location

Lankenau Institute for Medical Research

Wynnewood, Pennsylvania, 19096, United States

Location

Wellmont CVA Heart Institute

Kingsport, Tennessee, 37660, United States

Location

MeSH Terms

Conditions

Peripheral Arterial Disease; Peripheral Vascular Diseases

Condition Hierarchy (Ancestors)

Atherosclerosis; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Gary Ansel, MD

  OhioHealth Research Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: May 4, 2017
• First Posted: May 11, 2017
• Study Start: May 25, 2017
• Primary Completion: October 29, 2018
• Study Completion: October 29, 2018
• Last Updated: November 14, 2018

Record last verified: 2018-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (3)