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

Natural Vascular Scaffolding (NVS) Therapy for the Treatment of Atherosclerotic Lesions in the Superficial Femoral Artery (SFA) and/or Proximal Popliteal Artery (PPA)

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.

Study Overview

• Status: Completed
• Conditions: Peripheral Arterial Disease; Peripheral Vascular Diseases; Catheterization, Peripheral
• Intervention / Treatment: Combination product: NVS Therapy

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.

• Study Type: Interventional
• Enrollment (Actual): 9
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Louisiana
    • Houma, Louisiana, United States, 70360
      • Cardiovascular Institute of the South
  • Michigan
    • Saginaw, Michigan, United States, 48604
      • Mid-Michigan Heart & Vascular Center
  • North Carolina
    • Raleigh, North Carolina, United States, 27606
      • NC Heart & Vascular Research
  • Tennessee
    • Kingsport, Tennessee, United States, 37660
      • Wellmont CVA Heart Institute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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:

1. Subject is at least 18 years of age.
2. 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.
3. Subject is eligible for PTA.
4. Subject is willing to comply with all protocol required follow-up evaluations.
5. Subject has documented Rutherford Classification 2 to 4 (see Appendix 3).
6. Subject has laboratory test results that are within clinically acceptable limits.
7. In investigator's opinion, subject is hemodynamically stable at the time of the index procedure.
8. Subject has a life expectancy of ≥ 1 year in the opinion of the Investigator.
9. Subject is able to tolerate the insertion of a 7F sheath into the common femoral artery (CFA), as determined by the investigator.
10. 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:

1. 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.
2. Subject has any permanent neurologic defect that may impair ambulation and/or cause non-compliance with the protocol.
3. Subject had a STEMI or NSTEMI within the last 3 months prior to enrollment.
4. 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.
5. Subject is currently receiving oral or intravenous immunosuppressive therapy (e.g., inhaled steroids are not excluded).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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 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)

Collaborators and Investigators

• Sponsor: Alucent Biomedical
• Investigators: Study Director: Henry Hauser, Alucent Biomedical

Study record dates

Study Major Dates

• Study Start (ACTUAL): May 22, 2020
• Primary Completion (ACTUAL): April 5, 2022
• Study Completion (ACTUAL): May 31, 2022

Study Registration Dates

• First Submitted: December 4, 2019
• First Submitted That Met QC Criteria: December 4, 2019
• First Posted (ACTUAL): December 5, 2019

Study Record Updates

• Last Update Posted (ACTUAL): July 14, 2022
• Last Update Submitted That Met QC Criteria: July 13, 2022
• Last Verified: July 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Atherosclerosis; Vascular Diseases; Peripheral Arterial Disease; Peripheral Vascular Diseases
• Other Study ID Numbers: 1060-002

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: Yes