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

NCT ID: NCT04188262

Last Updated: 2022-07-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 9 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-05-22
• Study Completion Date: 2022-05-31

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.

Conditions

Peripheral Arterial Disease; Peripheral Vascular Diseases; Catheterization, Peripheral

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

NVS Therapy

Intervention Type: 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.

Interventions

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.

Intervention Type: COMBINATION_PRODUCT

Other Intervention Names

Natural Vascular Scaffold

Eligibility Criteria

Inclusion Criteria

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).

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Alucent Biomedical

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Henry Hauser

Role: STUDY_DIRECTOR

Alucent Biomedical

Locations

Cardiovascular Institute of the South

Houma, Louisiana, United States

Mid-Michigan Heart & Vascular Center

Saginaw, Michigan, United States

NC Heart & Vascular Research

Raleigh, North Carolina, United States

Wellmont CVA Heart Institute

Kingsport, Tennessee, United States

Countries

United States

Other Identifiers

1060-002

Identifier Type: -

Identifier Source: org_study_id