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

• ClinicalTrials.gov Identifier: NCT04188262
• Recruitment Status: Completed
• First Posted: December 5, 2019
• Last Update Posted: July 14, 2022
• Sponsor: Alucent Biomedical
• Information provided by (Responsible Party): Alucent Biomedical

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.

Condition or disease	Intervention/treatment	Phase
Peripheral Arterial Disease; Peripheral Vascular Diseases; Catheterization, Peripheral	Combination Product: NVS Therapy	Phase 1

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 Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 9 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Intervention 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)
• Primary Purpose: Treatment
• 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)
• Actual Study Start Date: May 22, 2020
• Actual Primary Completion Date: April 5, 2022
• Actual Study Completion Date: May 31, 2022

Arms and Interventions

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 Name: Natural Vascular Scaffold

Outcome Measures

Primary Outcome Measures :

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

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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:

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).

Contacts and Locations

Locations

United States, Louisiana

Cardiovascular Institute of the South

Houma, Louisiana, United States, 70360

United States, Michigan

Mid-Michigan Heart & Vascular Center

Saginaw, Michigan, United States, 48604

United States, North Carolina

NC Heart & Vascular Research

Raleigh, North Carolina, United States, 27606

United States, Tennessee

Wellmont CVA Heart Institute

Kingsport, Tennessee, United States, 37660

Sponsors and Collaborators

Alucent Biomedical

Investigators

• Study Director: Henry Hauser; Alucent Biomedical

More Information

• Responsible Party: Alucent Biomedical
• ClinicalTrials.gov Identifier: NCT04188262
• Other Study ID Numbers: 1060-002
• First Posted: December 5, 2019
• Last Update Posted: July 14, 2022
• Last Verified: July 2022

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• 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

Additional relevant MeSH terms:

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