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

NCT04188262 | Completed Phase 1 DMC FDA Drug FDA Device

• 1 other identifier: 1060-002
• Study Type: interventional
• Target: 9
• Locations: 1 country
• Sites: 4

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.

Conditions

Peripheral Arterial Disease; Peripheral Vascular Diseases; Catheterization, Peripheral

Outcome Measures

Primary Outcomes (2)

• 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)

Study Arms (1)

NVS Therapy

EXPERIMENTAL

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

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

NVS Therapy

Eligibility Criteria

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

You may not qualify if:

• 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).

Sponsors & Collaborators

• Alucent Biomedical: lead

Study Sites (4)

Cardiovascular Institute of the South

Houma, Louisiana, 70360, United States

Location

Mid-Michigan Heart & Vascular Center

Saginaw, Michigan, 48604, United States

Location

NC Heart & Vascular Research

Raleigh, North Carolina, 27606, 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

• Henry Hauser

  Alucent Biomedical

  STUDY DIRECTOR

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: December 4, 2019
• First Posted: December 5, 2019
• Study Start: May 22, 2020
• Primary Completion: April 5, 2022
• Study Completion: May 31, 2022
• Last Updated: July 14, 2022

Record last verified: 2022-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (4)