Feasibility Study of the Vessel Restoration System (VRS): ACTIVATE II

NCT05454995 | Active Not Recruiting DMC

• 1 other identifier: 1061-001
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

Feasibility Study of the Vessel Restoration System (VRS) for the Treatment of Atherosclerotic Lesions in the Superficial Femoral Artery (SFA) and/or Proximal Popliteal Artery (PPA): ACTIVATE II

Conditions

PAD - Peripheral Arterial Disease

Outcome Measures

Primary Outcomes (2)

• To assess the safety

  To assess the safety of the VRS by way of occurence of advese events during the index procedure

  12 months

• To assess efficacy

  To assess the efficacy of the VRS as determined by lesion patency through 1 year

  12 months

Study Arms (1)

Alucent VRS for Treatment of Atherosclerotic Lesions

EXPERIMENTAL

Combination Product: VRS

Other: Vessel Restoration System (VRS)

Interventions

Vessel Restoration System (VRS) OTHER

Vessel Restoration System (VRS) for the Treatment of Atherosclerotic Lesions in the Superficial Femoral Artery (SFA) and/or Proximal Popliteal Artery (PPA)

Alucent VRS for Treatment of Atherosclerotic Lesions

Eligibility Criteria

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

You may qualify if:

• Subject (or Legal Guardian) is willing and able to provide consent before any study-specific tests or procedures are performed and agree to attend all required follow-up visits.
• Male or female subject of at least 18 years of age.
• Chronic symptomatic lower limb ischemia defined as Rutherford classification 2, 3, or 4.

You may not qualify if:

• Life expectancy, documented in the Investigator's opinion, of less than 1 year.
• Cerebrovascular accident (CVA) or transient ischemic attack (TIA) or cardiac event (e.g., PCI for STEMI/NSTEMI, unstable angina) within 6 months prior to the index procedure.
• Known allergies or sensitivities to heparin, aspirin (ASA), other anticoagulant/antiplatelet therapies.
• Use of rivaroxaban 2.5 mg BID with low-dose aspirin for the treatment of patients with symptomatic peripheral arterial disease is permitted as per local standard of care. Use of rivaroxaban 2.5 mg in conjunction with dual antiplatelet therapy (low-dose aspirin and a secondary agent) is not permitted.
• Known hypersensitivity or contraindication to contrast dye that, in the opinion of the investigator, cannot be adequately pre-medicated.
• Chronic renal insufficiency with serum creatinine ≥2.5 mg/dL or eGFR \<45 ml/min within 30 days prior to the index procedure or treatment with peritoneal or hemodialysis.
• Subject has a platelet count \< 100,000 cells/mm3 or \> 700,000 cells/mm3 within 30 days prior to the index procedure or has a history of bleeding diathesis.
• Receiving oral or intravenous immunosuppressive therapy.
• Subject is currently receiving a medication that causes photosensitivity, with a prior documented photosensitive reaction.
• Subject has white blood cell (WBC) count \<3.0 (3,000 cells/mm3) within 30 days prior to the index procedure.
• Subject has known or suspected active systemic infection evidenced by WBC \> 14.0 (14,000/mm3).
• History of major amputation in the target limb.
• Any major intervention planned at the index procedure or within 30 days post-index procedure including treatment of contralateral limb.
• Any arterial access other than contralateral common femoral artery (CFA) or ipsilateral antegrade CFA is required to gain access to target vessel. All popliteal and infrapopliteal ipsilateral retrograde access are excluded.
• Subject has any permanent neurologic defect that may impair ambulation and/or cause non-compliance with the protocol.

Sponsors & Collaborators

• Alucent Biomedical: lead

Study Sites (1)

Flinders Medical Center

Adelaide, South Australia, Australia

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• 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: July 8, 2022
• First Posted: July 13, 2022
• Study Start: November 15, 2021
• Primary Completion (Estimated): November 15, 2027
• Study Completion (Estimated): November 15, 2027
• Last Updated: January 16, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

AU (1)