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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT05454995




Registration number
NCT05454995
Ethics application status
Date submitted
8/07/2022
Date registered
13/07/2022

Titles & IDs
Public title
Feasibility Study of the Vessel Restoration System (VRS): ACTIVATE II
Scientific title
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
Secondary ID [1] 0 0
1061-001
Universal Trial Number (UTN)
Trial acronym
ACTIVATEII
Linked study record

Health condition
Health condition(s) or problem(s) studied:
PAD - Peripheral Arterial Disease 0 0
Condition category
Condition code
Cardiovascular 0 0 0 0
Diseases of the vasculature and circulation including the lymphatic system

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Other interventions - Vessel Restoration System (VRS)

Experimental: Alucent VRS for Treatment of Atherosclerotic Lesions - Combination Product: VRS


Other interventions: Vessel Restoration System (VRS)
Vessel Restoration System (VRS) for the Treatment of Atherosclerotic Lesions in the Superficial Femoral Artery (SFA) and/or Proximal Popliteal Artery (PPA)
Intervention code [1] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
To assess the safety
Timepoint [1] 0 0
12 months
Primary outcome [2] 0 0
To assess efficacy
Timepoint [2] 0 0
12 months

Eligibility
Key inclusion criteria
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.

General
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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. Known allergies or sensitivities to heparin, aspirin (ASA), other anticoagulant/antiplatelet therapies.
4. 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.
5. Known hypersensitivity or contraindication to contrast dye that, in the opinion of the investigator, cannot be adequately pre-medicated.
6. 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.
7. 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.
8. Receiving oral or intravenous immunosuppressive therapy.
9. Subject is currently receiving a medication that causes photosensitivity, with a prior documented photosensitive reaction.
10. Subject has white blood cell (WBC) count <3.0 (3,000 cells/mm3) within 30 days prior to the index procedure.
11. Subject has known or suspected active systemic infection evidenced by WBC > 14.0 (14,000/mm3).
12. History of major amputation in the target limb.
13. Any major intervention planned at the index procedure or within 30 days post-index procedure including treatment of contralateral limb.
14. 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.
15. Subject has any permanent neurologic defect that may impair ambulation and/or cause non-compliance with the protocol.
16. Subject has an active peptic ulcer or active gastrointestinal (GI) bleeding within 6 months prior to the index procedure.
17. Subject has documented or suspected liver disease, including laboratory evidence of hepatitis.
18. Subject is currently on oral anticoagulation therapy, such as warfarin, rivaroxaban, apixaban, or dabigatran etexilate, except when the subject is prescribed such medication as treatment for atrial fibrillation (medication and/or following ablation therapies and/or left atrial appendage occlusion procedure). Use of low-dose rivaroxaban 2.5 mg BID and low-dose aspirin to treat patients with symptomatic peripheral arterial disease is permitted as per local standard of care.
19. Subject is planned to undergo treatment with the ShockWave® IVL (ShockWave Medical Inc. Santa Clara, CA, USA) and/or any adjunctive pre-dilatation vessel preparation angioplasty device.
20. 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.
21. Current or planned (within one-year post-index procedure) participation in another investigational drug or device clinical trial that has not completed the primary endpoint at the time of randomization/enrollment or that clinically interferes with the current trial endpoints.
22. Any concurrent condition which in the investigator's opinion makes it undesirable for the subject to participate in the trial or which would jeopardize compliance with the protocol and follow-up visits.

Study design
Purpose of the study
Treatment
Allocation to intervention
Not applicable
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
15/11/2021
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
15/11/2027
Actual
Sample size
Target
50
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
SA
Recruitment hospital [1] 0 0
Flinders Medical Center - Adelaide
Recruitment postcode(s) [1] 0 0
- Adelaide

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Alucent Biomedical
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT05454995