Peripheral Artery DiseaseREMODEL INCT07575568
Revascularization With Modification Using Definitive IVL and Serration Remodeling for Optimal Lumen
A study testing Serranator Sonic Intravascular Lithotripsy (IVL) System in people with Peripheral Artery Disease, run by Cagent Vascular LLC.
Trial summary
The objective of this first-in-human study is to assess the safety and effectiveness of the Serranator Sonic Intravascular Lithotripsy (IVL) System™ for the treatment of peripheral artery disease. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Peripheral Artery Disease
- What is being tested?
- Serranator Sonic Intravascular Lithotripsy (IVL) System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- May 2026to Sep 2027
- 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
- Clinical:
- Subject is ≥ 18 years of age
- Target limb is Rutherford Clinical Category 2, 3 or 4
- Resting ABI of ≤0.90, or TBI ≤0.70 of the target limb
- Angiographic:
- Subject must have a de novo target lesion in a native superficial femoral artery (SFA) or popliteal artery
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- Reference vessel diameter (RVD) between 4.0 and 8.0mm
- Target lesion must have a diameter stenosis of ≥70%
- Lesion calcification is at least moderate
- Total planned target lesion length must be ≤150mm
- Chronic total occlusion lesion length is ≤100mm
- Subject has at least one patent tibial vessel on the target limb with runoff to the foot
- Clinical:
- Age of subject is ≥18
- Rutherford Clinical Category 2 - 5 (with tissue loss limited to the digits and no evidence of infection)
- Angiographic:
- Single or two target lesion(s) located in a de novo artery distal to the trifurcation vessels
- Target vessel reference diameter is between 2.5mm and 4.0 mm
- Target lesion with diameter stenosis ≥50%
- Target lesion is ≤150mm in length
- Subject has at least one patent tibial vessel (>50%) with run-off to the foot.
- Calcification is at least moderate
Who cannot join
- Clinical:
- Rutherford Clinical Categories 0, 1, 5 and 6
- Subject with known pregnancy or is nursing
- Subject has acute or chronic renal disease, defined as serum creatinine of >2.5 mg/dL or >220 µmol/L or on dialysis
- Angiographic:
- Target lesions >150mm by visual estimation
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- Chronic total occlusions > 100mm by visual estimation
- No or mild calcium present in the target lesion
- Clinical:
- Rutherford Clinical Category 0,1 or 6
- Gangrene of the lower extremity
- Patient is pregnant or nursing
- Angiographic:
- Target lesion is within only lower extremity vessel with < 50% stenosis
- Target lesion length exceeds 150mm
- Patient has chronic total occlusion of target lesion
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: REMODEL I: Revascularization With Modification Using Definitive IVL and Serration Remodeling for Optimal Lumen
The objective of this first-in-human study is to assess the safety and effectiveness of the Serranator Sonic Intravascular Lithotripsy (IVL) System™ for the treatment of peripheral artery disease.
- Conditions
- Peripheral Artery Disease
- Being tested
- Serranator Sonic Intravascular Lithotripsy (IVL) System
- Medical subject headings
- Peripheral Arterial Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Serranator Sonic Intravascular Lithotripsy (IVL) SystemDevice
Serration remodeling balloon angioplasty with Intravascular Lithotripsy of the superficial femoral and popliteal arteries for Cohort A: Above-the-Knee; treatment of the infrapopliteal and inframalleolar arteries for Cohort B: Below-the-Knee.
| Study group | Role | What they receive |
|---|---|---|
| Above-the-Knee | Experimental | For blockages in the legs that occur above the knee. Receives: Device: Serranator Sonic Intravascular Lithotripsy (IVL) System |
| Below-the-Knee | Experimental | For blockages in the legs that occur below the knee. Receives: Device: Serranator Sonic Intravascular Lithotripsy (IVL) System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary Safety: Major Adverse Events
Primary Safety: Major Adverse Events (MAE), measured at 30 days and defined as a composite of:
- All cardiovascular death
- Major amputation
- Clinically-driven target lesion revascularization (CD-TLR)
Measured: 30 Days
Primary Effectiveness: Procedural Success
Procedural Success, defined as:
<50% residual stenosis of the target lesion (with or without adjunctive PTA therapy and/or stenting) by angiographic core-lab assessment
Measured: Procedure
Secondary outcomes (9)
Freedom from Major Adverse Events at 6 months
Freedom from Major Adverse Events, defined as a composite of all cardiovascular death, major amputation, and clinically-driven target lesion revascularization
Measured: 6 months
Freedom from Major Adverse Events at 12 months
Freedom from Major Adverse Events defined as a composite of all cardiovascular death, major amputation, and clinically-driven target lesion revascularization.
Measured: 12 months
Procedural success of ≤30% residual stenosis of the target lesion
Procedural success of ≤30% residual stenosis of the target lesion (with or without adjunctive PTA therapy and/or stenting) by angiographic core lab assessment
Measured: Procedure
Patency rates of target lesion by duplex ultrasound
Patency rates at 30 days, 6 months, and 12 months of target lesion by duplex ultrasound. Target vessel patency by duplex ultrasound, defined as freedom from > 50% restenosis, as assessed by duplex ultrasound peak systolic velocity ratio of ≥2.5
Measured: 30 Days, 6 Months, and 12 Months
Freedom from clinically-driven target lesion revascularization
Freedom from clinically-driven target lesion revascularization (CD-TLR) at 30 days, 6 months, and 12 months
Measured: 30 Days, 6 Months, and 12 Months
Change in Ankle-Brachial Index/Toe-Brachial Index
Change in Ankle-Brachial Index/Toe-Brachial Index (TBI) at 30 days, 6 months, and 12 months, as compared to baseline
Measured: 30 Days, 6 Months, and 12 Months
Change in Rutherford Category
Change in Rutherford Category at 30 days, 6 months and 12 months, as compared to baseline
Measured: 30 Days, 6 Months, and 12 Months
Change in Walking Impairment Questionnaire score
Change in Walking Impairment Questionnaire (WIQ) score at 30 days, 6 months and 12 months, as compared to baseline
Measured: 30 Days, 6 Months, and 12 Months
Change in EuroQol-5D-3L
Change in EuroQol-5D-3L (EQ-5D-3L) at 30 days, 6 months and 12 months, as compared to baseline
Measured: 30 Days, 6 Months, and 12 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 May 2026
- Study startMay 2026 (estimated)
- Primary completionAug 2026 (estimated)
- Study completionSep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Peripheral Artery 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
- Parallel groups
- Model description
- Patients can have a lesion above the knee treated or up to 2 lesions below the knee treated.
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cagent Vascular LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Clinical Accelerator, Australian Healthcare Solutions, Yale Cardiovascular Research Group
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07575568
- Sponsor's protocol ID
- CSP-1179
- Acronym
- REMODEL I
- Status last verified
- May 2026
- First submitted
- 4 May 2026
- Last updated
- 8 May 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 8 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- REMODEL I: Revascularization With Modification Using Definitive IVL and Serration Remodeling for Optimal Lumen
- ClinicalTrials.gov ID
- NCT07575568
- Acronym / sponsor ID
- REMODEL I / CSP-1179
- Conditions
- Peripheral Artery Disease
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Cagent Vascular LLCIndustry (pharma, biotech, devices)
- Collaborators
- Clinical Accelerator, Australian Healthcare Solutions, Yale Cardiovascular Research Group
- Study start
- May 2026 (estimated)
- Primary completion
- Aug 2026 (estimated)
- Study completion
- Sep 2027 (estimated)
- First posted
- 8 May 2026 (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.
The objective of this first-in-human study is to assess the safety and effectiveness of the Serranator Sonic Intravascular Lithotripsy (IVL) System™ for the treatment of peripheral artery disease.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Patients can have a lesion above the knee treated or up to 2 lesions below the knee treated.
| Arm | Type | Receives |
|---|---|---|
| Above-the-Knee | Experimental | Device: Serranator Sonic Intravascular Lithotripsy (IVL) SystemFor blockages in the legs that occur above the knee. |
| Below-the-Knee | Experimental | Device: Serranator Sonic Intravascular Lithotripsy (IVL) SystemFor blockages in the legs that occur below the knee. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (22 listed)
- Subject is ≥ 18 years of age
- Target limb is Rutherford Clinical Category 2, 3 or 4
- Resting ABI of ≤0.90, or TBI ≤0.70 of the target limb
- Subject must have a de novo target lesion in a native superficial femoral artery (SFA) or popliteal artery
- Reference vessel diameter (RVD) between 4.0 and 8.0mm
Key exclusion criteria (16 listed)
- Rutherford Clinical Categories 0, 1, 5 and 6
- Subject with known pregnancy or is nursing
- Subject has acute or chronic renal disease, defined as serum creatinine of >2.5 mg/dL or >220 µmol/L or on dialysis
- Target lesions >150mm by visual estimation
- Chronic total occlusions > 100mm by visual estimation
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 |
|---|---|---|
| Serranator Sonic Intravascular Lithotripsy (IVL) SystemSerration remodeling balloon angioplasty with Intravascular Lithotripsy of the superficial femoral and popliteal arteries for Cohort A: Above-the-Knee; treatment of the infrapopliteal and inframalleolar arteries for Cohort B: Below-the-Knee. | Device | Above-the-Knee, Below-the-Knee |
Primary outcome
Primary Safety: Major Adverse Events
Time frame: 30 Days
Primary Safety: Major Adverse Events (MAE), measured at 30 days and defined as a composite of: * All cardiovascular death * Major amputation * Clinically-driven target lesion revascularization (CD-TLR)
Primary Effectiveness: Procedural Success
Time frame: Procedure
Procedural Success, defined as: <50% residual stenosis of the target lesion (with or without adjunctive PTA therapy and/or stenting) by angiographic core-lab assessment
9 secondary outcomes
Freedom from Major Adverse Events at 6 months
Time frame: 6 months
Freedom from Major Adverse Events at 12 months
Time frame: 12 months
Procedural success of ≤30% residual stenosis of the target lesion
Time frame: Procedure
Patency rates of target lesion by duplex ultrasound
Time frame: 30 Days, 6 Months, and 12 Months
Freedom from clinically-driven target lesion revascularization
Time frame: 30 Days, 6 Months, and 12 Months
Change in Ankle-Brachial Index/Toe-Brachial Index
Time frame: 30 Days, 6 Months, and 12 Months
Change in Rutherford Category
Time frame: 30 Days, 6 Months, and 12 Months
Change in Walking Impairment Questionnaire score
Time frame: 30 Days, 6 Months, and 12 Months
Change in EuroQol-5D-3L
Time frame: 30 Days, 6 Months, and 12 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 8 May 2026.
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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.
Questions about this trial
What is this clinical trial studying?
A study testing Serranator Sonic Intravascular Lithotripsy (IVL) System in people with Peripheral Artery Disease, run by Cagent Vascular LLC.
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 22 inclusion and 16 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: opening soon, as of the sponsor's last update on 8 May 2026. Status can change between updates, so confirm with the study contact before making plans.
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?
Contact Alexis Shewfelt (650-208-6743, ashewfelt33@cagentvascular.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Primary Safety: Major Adverse Events (time frame: 30 Days). 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 8 May 2026.