PAD - Peripheral Arterial DiseaseREACTIVATE INCT05455021
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
A study testing Vessel Restoration System (VRS) in people with PAD - Peripheral Arterial Disease, run by Alucent Biomedical at 2 sites in Australia.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- PAD - Peripheral Arterial Disease
- What is being tested?
- Vessel Restoration System (VRS)
- How many people
- 50 participants
- Where
- 2 sitesAustralia
- Study dates
- 15 Nov 2021to 15 Nov 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects for this study must meet all of the following general eligibility criteria
- AND the answer must be "YES" to all general inclusion criteria:
- 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.
- Has screen failed from the ACTIVATE II study due to the presence of Grade C or D dissection(s).
Who cannot join
- 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.
- 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 has white blood cell (WBC) count < 3.0 (3,000 cells/mm3) within 30 days prior to the index procedure.
Show all 9Show fewer
- 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.
- 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.
Trial locations and contacts
2 sites in 1 country.
Australia2 sites
Flinders Medical Center
Adelaide, South Australia
The Alfred Hospital
Melbourne, Victoria
About this study
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
- Conditions
- PAD - Peripheral Arterial Disease
- Being tested
- Vessel Restoration System (VRS)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vessel Restoration System (VRS)Combination product
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
An acute reduction in arterial dissections
Reduction in arterial dissection(s) of at least one grade.
Measured: 12 months
Primary Patency as assessed by Doppler Ultrasound (DUS) and freedom from CD-TLR at 1 Year
Primary Patency as assessed by Doppler Ultrasound (DUS)
Measured: 12 months
Secondary outcomes (7)
Technical Success
Technical success is defined by successful delivery of the VRS
Measured: 12 months
Procedural Success
Procedural Success is defined as an acute reduction in arterial dissection(s)
Measured: 12 months
Clinical Success
Clinical success is defined as freedom from CD-TLR
Measured: 36 months
Safety Measure
Frequency of MAEs
Measured: 72 months
Hemodynamic Improvement
Rate of hemodynamic improvement ABI
Measured: 36 months
Rutherford Classification
As assessed by changes in Rutherford Class
Measured: 36 months
Quality of Life Measure
Quality of life (QOL) assessment by EQ-5D
Measured: 72 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jul 2022
- Study start15 Nov 2021
- Primary completion15 Nov 2026 (estimated)
- Study completion15 Nov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PAD - Peripheral Arterial DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Model description
- This study is a prospective, nonrandomized, multicenter, open-label feasibility study of the VRS for the treatment of atherosclerotic de novo or restenotic lesions in the SFA and/or PA after sub-optimal PTA or atherectomy angiographic outcomes.
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Alucent Biomedical
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05455021
- Sponsor's protocol ID
- 1061-002
- Acronym
- REACTIVATE I
- Status last verified
- Jan 2024
- First submitted
- 8 Jul 2022
- Last updated
- 16 Jan 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Not sharing IPD
Study at a glance
From the registry record, last updated by the sponsor on 16 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT05455021
- Acronym / sponsor ID
- REACTIVATE I / 1061-002
- Conditions
- PAD - Peripheral Arterial Disease
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Alucent BiomedicalIndustry (pharma, biotech, devices)
- Study start
- 15 Nov 2021 (actual)
- Primary completion
- 15 Nov 2026 (estimated)
- Study completion
- 15 Nov 2026 (estimated)
- First posted
- 13 Jul 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Model description
- This study is a prospective, nonrandomized, multicenter, open-label feasibility study of the VRS for the treatment of atherosclerotic de novo or restenotic lesions in the SFA and/or PA after sub-optimal PTA or atherectomy angiographic outcomes.
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Subjects for this study must meet all of the following general eligibility criteria
- 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.
- Has screen failed from the ACTIVATE II study due to the presence of Grade C or D dissection(s).
Key exclusion criteria (9 listed)
- 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.
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Combination product | – |
Primary outcome
An acute reduction in arterial dissections
Time frame: 12 months
Reduction in arterial dissection(s) of at least one grade.
Primary Patency as assessed by Doppler Ultrasound (DUS) and freedom from CD-TLR at 1 Year
Time frame: 12 months
Primary Patency as assessed by Doppler Ultrasound (DUS)
7 secondary outcomes
Technical Success
Time frame: 12 months
Procedural Success
Time frame: 12 months
Clinical Success
Time frame: 36 months
Safety Measure
Time frame: 72 months
Hemodynamic Improvement
Time frame: 36 months
Rutherford Classification
Time frame: 36 months
Quality of Life Measure
Time frame: 72 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jan 2024.
- Individual participant dataSharing planned: No. Not sharing IPD
Related trials for PAD - Peripheral Arterial Disease
Active, not recruiting
SUCCESS (SelUtion, Safety, effiCaCy, hEalth economicS and promS) PTA Study
Peripheral Artery Disease
RecruitingPhase 3
Reducing Adverse Vascular Outcomes With Factor XI Inhibition in Adult Participants With Peripheral Artery Disease
Peripheral Artery Disease (PAD)
Recruiting
The THOR IDE Study
Peripheral Artery Disease, Peripheral Artery Stenosis
Not yet recruiting
Daily Stretching to Improve Walking in Older Patients With Peripheral Artery Disease: The STRETCH PAD Study
Peripheral Artery Disease (PAD), Intermittent Claudication
Enrolling by invitationEarly Phase 1
Truway Diagnostic Tools in Primary Care
Chronic Disease, Type 2 Diabetes Mellitus (T2DM), Obesity, Overweight
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Vessel Restoration System (VRS) in people with PAD - Peripheral Arterial Disease, run by Alucent Biomedical at 2 sites in Australia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 16 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
An acute reduction in arterial dissections (time frame: 12 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jan 2024.