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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT05455021




Registration number
NCT05455021
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) 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
Scientific title
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
Secondary ID [1] 0 0
1061-002
Universal Trial Number (UTN)
Trial acronym
REACTIVATE I
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)

Other interventions: Vessel 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.
Intervention code [1] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
An acute reduction in arterial dissections
Assessment method [1] 0 0
Reduction in arterial dissection(s) of at least one grade.
Timepoint [1] 0 0
12 months
Primary outcome [2] 0 0
Primary Patency as assessed by Doppler Ultrasound (DUS) and freedom from CD-TLR at 1 Year
Assessment method [2] 0 0
Primary Patency as assessed by Doppler Ultrasound (DUS)
Timepoint [2] 0 0
12 months
Secondary outcome [1] 0 0
Technical Success
Assessment method [1] 0 0
Technical success is defined by successful delivery of the VRS
Timepoint [1] 0 0
12 months
Secondary outcome [2] 0 0
Procedural Success
Assessment method [2] 0 0
Procedural Success is defined as an acute reduction in arterial dissection(s)
Timepoint [2] 0 0
12 months
Secondary outcome [3] 0 0
Clinical Success
Assessment method [3] 0 0
Clinical success is defined as freedom from CD-TLR
Timepoint [3] 0 0
36 months
Secondary outcome [4] 0 0
Safety Measure
Assessment method [4] 0 0
Frequency of MAEs
Timepoint [4] 0 0
72 months
Secondary outcome [5] 0 0
Hemodynamic Improvement
Assessment method [5] 0 0
Rate of hemodynamic improvement ABI
Timepoint [5] 0 0
36 months
Secondary outcome [6] 0 0
Rutherford Classification
Assessment method [6] 0 0
As assessed by changes in Rutherford Class
Timepoint [6] 0 0
36 months
Secondary outcome [7] 0 0
Quality of Life Measure
Assessment method [7] 0 0
Quality of life (QOL) assessment by EQ-5D
Timepoint [7] 0 0
72 months

Eligibility
Key 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).
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
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
Other
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
15/11/2026
Actual
Sample size
Target
50
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
SA,VIC
Recruitment hospital [1] 0 0
Flinders Medical Center - Adelaide
Recruitment hospital [2] 0 0
The Alfred Hospital - Melbourne
Recruitment postcode(s) [1] 0 0
- Adelaide
Recruitment postcode(s) [2] 0 0
- Melbourne

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

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Public notes

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

Data sharing statement


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/NCT05455021