Critical Limb IschemiaNCT06434194
Serrantor OCT Study
A study testing Serranator PTA Serration Catheter in people with Critical Limb Ischemia, run by Cagent Vascular LLC at 2 sites in United States.
Trial summary
TA prospective randomized control trial to evaluate the serration angioplasty effect in BTK arteries with varying degrees of calcified plaque. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Critical Limb Ischemia
- What is being tested?
- Serranator PTA Serration Catheter
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 2 sitesUnited States
- Study dates
- 31 Oct 2024to 1 Jun 2025
- 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 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Rutherford clinical category 4-6 of the target limb
- Age of subjects is >18 years old
- Patients has given informed consent to participate in this study
Who cannot join
- De novo or restenotic (without prior stent) stenosis (≥70%) or occlusion
- Target lesion is in the BTK arteries, including below the knee popliteal, tibioperoneal trunk, tibial, peroneal, and pedal arteries.
- Angiographic visual estimated reference vessel diameter is between 2.0 and 5.0 mm.
- Lesion length less than 220 mm
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Wittwer contact
United States2 sites, 2 recruiting
- Recruiting
Columbia University
New York, New York, 10032
K Dalton
- Recruiting
Weill Cornell Medical
New York, New York, 10065
R Chu
About this study
Official title: Serranator OCT: Understanding the Mechanism of Action of Serration Angioplasty by Serranator Versus Conventional Balloon Angioplasty for below-the Knee (BTK) Artery Disease Using Optical Coherence Tomography (OCT)
TA prospective randomized control trial to evaluate the serration angioplasty effect in BTK arteries with varying degrees of calcified plaque.
- Conditions
- Critical Limb Ischemia
- Being tested
- Serranator PTA Serration Catheter, PTA (Standard of Care)
- Medical subject headings
- Chronic Limb-Threatening Ischemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Serranator PTA Serration CatheterDevice
The Serranator PTA Serration Balloon Catheter is an over-the-wire balloon dilatation catheter designed to perform percutaneous transluminal angioplasty (PTA) for peripheral indications.
PTA (Standard of Care)Drug
A percutaneous transluminal angioplasty catheter will be used to treat the target lesion.
| Study group | Role | What they receive |
|---|---|---|
| Serrantor | Active comparator | Subjects randomized to the Serranator Arm of the study will be treated with the Serranator PTA Serration Balloon Receives: Device: Serranator PTA Serration Catheter |
| PTA | Active comparator | Subjects randomized to the PTA Arm of the study will be treated with a standard of care percutaneous transluminal angioplasty (PTA) balloon. Receives: Drug: PTA (Standard of Care) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Residual Lumen Volume Stenosis
Residual lumen volume stenosis derived by OCT comparing Serration Angioplasty and conventional plain balloon angioplasty (PTA) measured at 10-15min post procedure. The lesion segment is defined as the entire treated segment where the balloon has been inflated.
Measured: Baseline
Secondary outcomes (6)
OCT Residual Diameter Stenosis
Residual stenosis as measured by OCT
Measured: Baseline
Angiography Residual Diameter Stenosis
Residual stenosis as measured by angiography
Measured: Baseline
Dissection Pattern
The incidence of dissection pattern between the study arms as reported by the OCT Corelab. The CoreLab will evaluate OCT images of each dissection including analysis of the length of the dissection, arc of the dissection, number of serrations, and the length of the serration.
Measured: Baseline
Correlation of Luminal Gain and Plaque Modification
The correlation of the plaque modification achieved as determine from the OCT evaluation after treatment with the Study Device to the luminal gain achieved by conventional angioplasty as evaluated by the Core Lab.
Measured: Baseline
Rate of Optimal PTA
Rate of procedures that achieve optimal PTA (<30% diameter stenosis without flow-limiting dissection measured by angiography)
Measured: Baseline
Bail-out Stenting
Rate of bail-out stenting
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 May 2024
- Study start31 Oct 2024
- Primary completion1 Jun 2025 (estimated)
- Study completion1 Jun 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Critical Limb IschemiaStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cagent Vascular LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06434194
- Sponsor's protocol ID
- CSP
- Status last verified
- May 2025
- First submitted
- 3 May 2024
- Last updated
- 18 May 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Serranator OCT: Understanding the Mechanism of Action of Serration Angioplasty by Serranator Versus Conventional Balloon Angioplasty for below-the Knee (BTK) Artery Disease Using Optical Coherence Tomography (OCT)
- ClinicalTrials.gov ID
- NCT06434194
- Acronym / sponsor ID
- CSP
- Conditions
- Critical Limb Ischemia
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Cagent Vascular LLCIndustry (pharma, biotech, devices)
- Study start
- 31 Oct 2024 (actual)
- Primary completion
- 1 Jun 2025 (estimated)
- Study completion
- 1 Jun 2025 (estimated)
- First posted
- 30 May 2024 (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.
TA prospective randomized control trial to evaluate the serration angioplasty effect in BTK arteries with varying degrees of calcified plaque.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Serrantor | Active comparator | Device: Serranator PTA Serration CatheterSubjects randomized to the Serranator Arm of the study will be treated with the Serranator PTA Serration Balloon |
| PTA | Active comparator | Drug: PTA (Standard of Care)Subjects randomized to the PTA Arm of the study will be treated with a standard of care percutaneous transluminal angioplasty (PTA) balloon. |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Rutherford clinical category 4-6 of the target limb
- Age of subjects is >18 years old
- Patients has given informed consent to participate in this study
Key exclusion criteria (4 listed)
- De novo or restenotic (without prior stent) stenosis (≥70%) or occlusion
- Target lesion is in the BTK arteries, including below the knee popliteal, tibioperoneal trunk, tibial, peroneal, and pedal arteries.
- Angiographic visual estimated reference vessel diameter is between 2.0 and 5.0 mm.
- Lesion length less than 220 mm
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 PTA Serration CatheterThe Serranator PTA Serration Balloon Catheter is an over-the-wire balloon dilatation catheter designed to perform percutaneous transluminal angioplasty (PTA) for peripheral indications. | Device | Serrantor |
| PTA (Standard of Care)A percutaneous transluminal angioplasty catheter will be used to treat the target lesion. | Drug | PTA |
Primary outcome
Residual Lumen Volume Stenosis
Time frame: Baseline
Residual lumen volume stenosis derived by OCT comparing Serration Angioplasty and conventional plain balloon angioplasty (PTA) measured at 10-15min post procedure. The lesion segment is defined as the entire treated segment where the balloon has been inflated.
6 secondary outcomes
OCT Residual Diameter Stenosis
Time frame: Baseline
Angiography Residual Diameter Stenosis
Time frame: Baseline
Dissection Pattern
Time frame: Baseline
Correlation of Luminal Gain and Plaque Modification
Time frame: Baseline
Rate of Optimal PTA
Time frame: Baseline
Bail-out Stenting
Time frame: Baseline
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 18 May 2025.
- Individual participant dataSharing planned: No
Related trials for Critical Limb Ischemia
Not yet recruiting
DCB Outcomes After Non-Compliant Balloon Vessel Preparation With or Without Scoring in Patients With Femoropopliteal Arterial Disease
Femoropopliteal Disease, Drug Coated Balloon
RecruitingEarly Phase 1
Nutrition in Patient With Critical Limb Ischemia
Critical Limb Ischemia, Malnutrition
RecruitingObservational study
CRUSH PAD: Real-world Outcomes Following Use of Shockwave Intravascular Lithotripsy (IVL) Technology in Calcified Common Femoral Lesions
Femoral Arterial Calcification, Peripheral Arterial Disease
RecruitingObservational study
Use of Thermal Imaging Camera to Assess Perfusion Before and After Vascular Intervention
Peripheral Arterial Disease, Critical Limb Ischemia
Active, not recruitingPhase 3
Trial to Assess Chelation Therapy in Critical Limb Ischemia
Critical Limb Ischemia, Diabetes
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.
Wittwer contact
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Serranator PTA Serration Catheter in people with Critical Limb Ischemia, run by Cagent Vascular LLC at 2 sites in United States.
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 3 inclusion and 4 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: looking for participants now, as of the sponsor's last update on 18 May 2025. 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 United States. 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?
Contact Feeny (4197878496, kjclinconsulting@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Residual Lumen Volume Stenosis (time frame: Baseline). 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 18 May 2025; AzTrials last refreshed its copy on 27 Oct 2026.