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

Phase 1

Completed

• Conditions: Peripheral Arterial Disease; Catheterization, Peripheral; Peripheral Vascular Diseases
• Interventions: Combination Product: NVS Therapy

• Registration Number: NCT04188262
• Lead Sponsor: Alucent Biomedical

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.

Study Timeline

• Study First Submitted: 2019-12-04
• Study First Submitted QC: 2019-12-04
• Study First Posted: 2019-12-05
• Study Start: 2020-05-22
• Primary Completion: 2022-04-05
• Study Completion: 2022-05-31
• Status Verified: 2022-07
• Last Update Submitted: 2022-07-13
• Last Update Posted: 2022-07-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 9

Inclusion Criteria

Not provided

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
NVS Therapy	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.

Primary Outcome Measures

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

Trial Locations

Locations (4)

NC Heart & Vascular Research; 🇺🇸 Raleigh, North Carolina, United States

Mid-Michigan Heart & Vascular Center; 🇺🇸 Saginaw, Michigan, United States

Cardiovascular Institute of the South; 🇺🇸 Houma, Louisiana, United States

Wellmont CVA Heart Institute; 🇺🇸 Kingsport, Tennessee, United States