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

Primary Purpose

Peripheral Arterial Disease, Peripheral Vascular Diseases, Catheterization, Peripheral

Status

Completed

Phase

Phase 1

Locations

United States

Study Type

Interventional

Intervention

NVS Therapy

About this trial

This is an interventional treatment trial for Peripheral Arterial Disease

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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).

Sites / Locations

Cardiovascular Institute of the South
Mid-Michigan Heart & Vascular Center
NC Heart & Vascular Research
Wellmont CVA Heart Institute

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

NVS Therapy

Arm Description

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.

Outcomes

Primary Outcome Measures

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.

NVS Drug Plasma Concentrations

The Peak Plasma Concentration (Cmax) will be determined from plasma 10-8-10 Dimer concentrations for blood samples collected.

Secondary Outcome Measures

Full Information

NCT ID

NCT04188262

First Posted

December 4, 2019

Last Updated

July 13, 2022

Sponsor

Alucent Biomedical

1. Study Identification

Unique Protocol Identification Number

NCT04188262

Brief Title

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

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)

Study Type

Interventional

2. Study Status

Record Verification Date

July 2022

Overall Recruitment Status

Completed

Study Start Date

May 22, 2020 (Actual)

Primary Completion Date

April 5, 2022 (Actual)

Study Completion Date

May 31, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Alucent Biomedical

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Yes

Device Product Not Approved or Cleared by U.S. FDA

Yes

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Peripheral Arterial Disease, Peripheral Vascular Diseases, Catheterization, Peripheral

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Single Group Assignment

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)

Allocation

N/A

Enrollment

9 (Actual)

8. Arms, Groups, and Interventions

Arm Title

NVS Therapy

Arm Type

Experimental

Arm Description

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.

Intervention Type

Combination Product

Intervention Name(s)

NVS Therapy

Other Intervention Name(s)

Natural Vascular Scaffold

Intervention Description

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.

Primary Outcome Measure Information:

Title

Freedom from all-cause mortality, freedom from target limb major amputation, freedom from target lesion revascularization (TLR).

Description

Time Frame

Day 30

Title

NVS Drug Plasma Concentrations

Description

The Peak Plasma Concentration (Cmax) will be determined from plasma 10-8-10 Dimer concentrations for blood samples collected.

Time Frame

Day 1 - 24 (Or Discharge)

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

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).

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Henry Hauser

Organizational Affiliation

Alucent Biomedical

Official's Role

Study Director

Facility Information:

Facility Name

Cardiovascular Institute of the South

City

Houma

State/Province

Louisiana

ZIP/Postal Code

70360

Country

United States

Facility Name

Mid-Michigan Heart & Vascular Center

City

Saginaw

State/Province

Michigan

ZIP/Postal Code

48604

Country

United States

Facility Name

NC Heart & Vascular Research

City

Raleigh

State/Province

North Carolina

ZIP/Postal Code

27606

Country

United States

Facility Name

Wellmont CVA Heart Institute

City

Kingsport

State/Province

Tennessee

ZIP/Postal Code

37660

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

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

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