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Active, not recruitingNCT05455021REACTIVATE IUpdated Jan 16, 2024

Feasibility Study of the Vessel Restoration System (VRS) for the Treatment of Atherosclerotic Lesions in the Superficial Femoral Artery (SFA) and/or Popliteal Artery (PA) After Sub-optimal Percutaneous Transluminal Angioplasty (PTA) or Atherectomy: REACTIVATE I

An interventional study of Vessel Restoration System (VRS) in PAD - Peripheral Arterial Disease, sponsored by Alucent Biomedical. Active, not recruiting at 2 sites in Australia. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-01-16.

Sponsored by Alucent Biomedical · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Registered 7 months after the study started (first participant enrolled Nov 2021, registered Jul 2022).
Phase
Not applicable
Study type
Interventional
Enrollment
50
Allocation
Non-randomized
Ages
18 Years and older
Sex
All
01

Study summary

Feasibility Study of the Vessel Restoration System (VRS) for the Treatment of Atherosclerotic Lesions in the Superficial Femoral Artery (SFA) and/or Popliteal Artery (PA) after Sub-optimal percutaneous transluminal angioplasty (PTA) or Atherectomy: REACTIVATE I

02

Conditions studied

  • PAD - Peripheral Arterial Disease
03

In context

Peripheral Arterial Disease

1,542 studies on the registry are indexed under Peripheral Arterial Disease; 282 are open to participants now.

This study's planned enrollment of 50 is below the median of 74 across 1,066 interventional studies indexed under Peripheral Arterial Disease.

Browse Peripheral Arterial Disease studies →

Lead sponsor

Alucent Biomedical is the lead sponsor of 5 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

Subjects for this study must meet all of the following general eligibility criteria

AND the answer must be "YES" to all general inclusion criteria:

  1. 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.
  2. Male or female subject of at least 18 years of age.
  3. Chronic symptomatic lower limb ischemia defined as Rutherford classification 2, 3, or 4.
  4. Has screen failed from the ACTIVATE II study due to the presence of Grade C or D dissection(s).

Exclusion criteria

Exclusion Criteria:

  1. Life expectancy, documented in the Investigator's opinion, of less than 1 year.
  2. 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.
  3. 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.
  4. 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.
  5. Receiving oral or intravenous immunosuppressive therapy.
  6. Subject has white blood cell (WBC) count \< 3.0 (3,000 cells/mm3) within 30 days prior to the index procedure.
  7. History of major amputation in the target limb.
  8. Any major intervention planned at the index procedure or within 30 days post-index procedure including treatment of contralateral limb.
  9. Subject is pregnant, breastfeeding, or planning to become pregnant in the next 30 days. Subjects (male and female) of childbearing potential must agree to use effective birth control measures for 30 days after the index procedure.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Sequential assignment
Masking
None (open label)
Enrollment
50 participants (estimated)

Interventions

  • Combination productVessel Restoration System (VRS)

    The VRS includes the following components: * VRS 10-8-10 Dimer Coated Balloon Catheter * VRS Light Fiber * VRS Light Source The VRS will collectively refer to all the components used to perform the procedure. Their specific product name will identify individual elements.

06

What researchers measure

Primary outcomes

  1. An acute reduction in arterial dissections

    Reduction in arterial dissection(s) of at least one grade.

    Time frame: 12 months

  2. Primary Patency as assessed by Doppler Ultrasound (DUS) and freedom from CD-TLR at 1 Year

    Primary Patency as assessed by Doppler Ultrasound (DUS)

    Time frame: 12 months

Secondary outcomes

  1. Technical Success

    Technical success is defined by successful delivery of the VRS

    Time frame: 12 months

  2. Procedural Success

    Procedural Success is defined as an acute reduction in arterial dissection(s)

    Time frame: 12 months

  3. Clinical Success

    Clinical success is defined as freedom from CD-TLR

    Time frame: 36 months

  4. Safety Measure

    Frequency of MAEs

    Time frame: 72 months

  5. Hemodynamic Improvement

    Rate of hemodynamic improvement ABI

    Time frame: 36 months

  6. Rutherford Classification

    As assessed by changes in Rutherford Class

    Time frame: 36 months

  7. Quality of Life Measure

    Quality of life (QOL) assessment by EQ-5D

    Time frame: 72 months

Other outcomes

  1. Major Adverse Limb Events

    Time frame: 36 months

  2. Reintervention for treatment of thrombosis of the target vessel or embolization to its distal Vasculature

    Time frame: 36 months

  3. Major Vascular Complications

    Time frame: 36 months

07

Study locations

2 sites
  • Flinders Medical Center
    Adelaide, South Australia, Australia
  • The Alfred Hospital
    Melbourne, Victoria, Australia
08

References and documents

Individual participant data

Plan to share: No — Not sharing IPD

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 16, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05455021
Lead sponsor
Alucent Biomedical
Responsible party
Sponsor
First posted
Jul 13, 2022
Start date
Nov 15, 2021
Primary completion
Nov 15, 2026 (estimated)
Completion
Nov 15, 2026 (estimated)
Last update
Jan 16, 2024

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is active, not recruiting, as verified in Jan 2024. You cannot join it, but the record below documents what was studied.

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Discussion

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