Peripheral Arterial DiseaseNCT03693963
The PRELUDE BTK Study
A study testing Serranator in people with Peripheral Arterial Disease and Critical Limb Ischemia, run by Cagent Vascular LLC at 6 sites in 4 countries.
Trial summary
The objective of the PRELUDE BTK study is to assess safety and efficacy of the Serranator® PTA Serration Balloon Catheter (study device) in subjects with atherosclerotic peripheral artery disease of the infrapopliteal arteries. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Peripheral Arterial Disease, Critical Limb Ischemia
- What is being tested?
- Serranator
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 49 participants
- Where
- 6 sitesin 4 countries
- Study dates
- 17 Dec 2019to 23 Oct 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- Male or female of >18 years old.
- Women of child bearing potential must have a negative urine pregnancy test within 7 days of index procedure.
- Subject or subject's legal representative has been informed of the nature of the study, agrees to participate and comply with all follow-up visits and has signed the consent form.
- Subject is eligible for standard surgical repair in target limb if necessary.
- Subject has Rutherford Clinical Category 3, 4 or 5. Enrollment of Rutherford 3 will be limited to no more than 40% of total subjects.
- Estimated life expectancy > 1 year.
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- Angiographic Inclusion Criteria:
- Target lesion(s) has stenosis >70% by visual assessment;
- De-novo, or non-stented re-stenotic lesions;
- Reference vessel diameter is between 2.5 mm and 3.5 mm, inclusive;
- Target lesions involve infra-popliteal tibial arteries above the tibio-talar joint;
- Up to two target lesion(s) may be treated. These target lesions may be located in a single or two infrapopliteal arteries;
- A target lesion may consist of one long or multiple serial lesions that are up to and including 12 cm in length that can be covered by a single balloon (longest balloon length for this study will be 12 cm);
- If more than one critical lesion is identified in two different vessels but only one lesion matches the inclusion criteria, that lesion should be treated as the target lesion and the other non-qualifying lesion in the other vessel may be treated with commercial devices in any manner the investigator decides except by atherectomy;
- If two critical lesions are identified in two vessels and both qualify for the study, the investigator may treat both lesions with investigational balloons or may choose to identify one lesion as the target lesion and treat the second lesion with commercial devices except atherectomy;
- If two critical lesions are in one vessel and both lesions qualify for the study, both lesions should be treated with investigational balloons. Lesions that are within 3 cm of each other will be treated as a single lesion;
- Target vessel(s) reconstituted at or above the ankle with inline flow to at least one patent inframalleolar outflow vessel in each target vessel. If the peroneal artery is the treated artery, it should supply collaterals at the ankle that reconstitute an inframalleolar outflow vessel;
- Successful treatment of inflow stenosis (DS>50%), from the iliac to the target lesion. Stenosis can be treated during the same procedure using standard angioplasty, DCB, DES, and/or stenting but use of atherectomy is excluded. The inflow lesion(s) must be treated first, prior to consideration of treatment of the target lesion. Subject can be enrolled if the inflow lesion(s) are treated and results in <30% residual stenosis and no evidence of embolization or significant complications.
Who cannot join
- Rutherford Clinical Category 1, 2, or 6
- Evidence of aneurysm or acute thrombus in the target vessel.
- Subjects with previous bypass surgery in lower target extremity.
- Planned major amputation (above the ankle) of either limb.
- Subject has significant stenosis or occlusion of inflow tract not successfully treated (>30% residual stenosis and/or significant complication of the procedure).
- History of any open surgical procedure within the past 30 days.
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- Planned endovascular procedure within 14 days prior to the BTK procedure, except to treat the inflow vessels on the day of the procedure, or a planned endovascular or open surgical procedure within the next 30 days after the BTK procedure on either limb.
- Planned intervention of occluded or stenotic pedal arteries at the time of the index procedure.
- Subject has an allergy to contrast medium that cannot be pretreated.
- Episode of acute limb ischemia within past 30 days.
- Subject has systemic infection with positive blood cultures/ bacteremia within one week.
- Subject has a hypercoagulable disorder
- Subject in whom antiplatelet, anticoagulant, or thrombolytic therapy is contraindicated.
- Myocardial infarction within 30 days prior to enrollment.
- History of stroke or TIA within 90 days prior to enrollment.
- Subject has acute or chronic renal disease (e.g., as measured by a serum creatinine of >2.5 mg/dL or >220 umol/L).
- Subject is pregnant or breastfeeding.
- Subject is participating in another research study of a device, medication, which could, in the opinion of the investigator, affect the results of this study.
- Subject has other medical, social or psychological problems that in the opinion of the investigator would preclude them from receiving this treatment and the procedures and or participating in evaluations pre- and post-treatment.
- Thrombolysis of the target vessel within 72 hours prior to the index procedure, where complete resolution of the thrombus was not achieved.
- Known allergies to both antiplatelet agents, aspirin, or heparin.
- History of neutropenia, coagulopathy, or thrombocytopenia that was unexplained or is considered to be at risk for reoccurrence.
- Platelet count less than 80,000/μL.
- Subject requires general anesthesia for the procedure.
- Subject requires dialysis.
- Subject has heel gangrene and anything worse than WIfI 2.
- Angiographic Exclusion Criteria:
- De-novo, or non-stented re-stenotic lesions or Chronic Total Occlusions (CTO) > 12 cm in length.
- Acute Total Occlusions; evidence of acute thrombus formation by angiography.
- In-stent restenotic lesions.
- Inability to cross the lesion with a guidewire.
- Atherectomy for inflow treatment or planned use in below the knee vessel(s)
- Intended use of adjunctive primary treatment modalities of target lesion(s) (atherectomy, laser, cutting balloons, DCBs, stents).
- If two critical lesions are in one vessel but only one lesion qualifies, and the other does not, the subject should not be included in the study
Trial locations and contacts
6 sites in 4 countries.
6 sites in 4 countries
Germany3 sites
Klinikum Hochsauerland GmbH
Arnsberg, 59759
Krankenhaus Buchholz
Buchholz, 21244
Imland Klinik Rendsburg
Rendsburg, 24768
About this study
Official title: PRospective Study for the TrEatment of Atherosclerotic Lesions in the Infrapopliteal Arteries Using the Serranator® DevicE: PRELUDE BTK (Below The Knee) Study
The objective of the PRELUDE BTK study is to assess safety and efficacy of the Serranator® PTA Serration Balloon Catheter (study device) in subjects with atherosclerotic peripheral artery disease of the infrapopliteal arteries.
Read the detailed description
Single arm, prospective, multi-center feasibility study enrolling up to 48 subjects with atherosclerotic lesions in the infrapopliteal arteries and/or Critical Limb Ischemia (CLI). The study will capture acute angiographic data to compare the pre-Serranator® inflation vs post inflation effects and will include 6 month clinical follow up.
The study population will consist of subjects with claudication or CLI, with de novo stenoses or non-stented restenotic or total occlusion lesions in infrapopliteal arteries having lesion length up to and including 12 cm in length and reference vessel diameter of 2.5 mm to 3.5 mm inclusive.
- Being tested
- Serranator
- Medical subject headings
- Peripheral Arterial Disease, Chronic Limb-Threatening Ischemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SerranatorDevice
The Serranator® PTA Serration Balloon Catheter is an over-the-wire (OTW) balloon dilatation catheter designed to perform percutaneous transluminal angioplasty (PTA) for peripheral indications.
| Study group | Role | What they receive |
|---|---|---|
| Single Arm, treated with Serranator | Other | Subjects treated with Serrantor Receives: Device: Serranator |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of MALE and POD (Safety)
Composite of Major Adverse Limb Events (MALE) and Peri-procedural Death (POD), assessed at 30 days post procedure. MALE plus POD is defined as a composite of all cause death, thrombolysis/thrombectomy at the target lesion, open surgical revision or bypass, and major (above ankle) target limb amputation at 30 days post procedure. Safety will be evaluated on a per subject basis.
Measured: 30 days post procedure
Secondary outcomes (1)
Rate of Device Success (Procedural Efficacy)
Procedural efficacy will be assessed by the rate of device success defined as the achievement of successful insertion, balloon inflation and deflation, and removal of the study device(s) with a final diameter stenosis of <50% by visual assessment at the intended target site using only the Serranator device. Device success will be evaluated on a per lesion basis.
Measured: Immediately Post Serranator treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Oct 2018
- Study start17 Dec 2019
- Primary completion11 Apr 2020
- Study completion23 Oct 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 49 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cagent Vascular LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03693963
- Sponsor's protocol ID
- CSP-0197
- Status last verified
- Jan 2020
- First submitted
- 20 Jul 2018
- Last updated
- 28 Jan 2021
- Results posted
- No
- Data monitoring committee
- 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 28 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PRospective Study for the TrEatment of Atherosclerotic Lesions in the Infrapopliteal Arteries Using the Serranator® DevicE: PRELUDE BTK (Below The Knee) Study
- ClinicalTrials.gov ID
- NCT03693963
- Acronym / sponsor ID
- CSP-0197
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 49 participants (actual)
- Lead sponsor
- Cagent Vascular LLCIndustry (pharma, biotech, devices)
- Study start
- 17 Dec 2019 (actual)
- Primary completion
- 11 Apr 2020 (actual)
- Study completion
- 23 Oct 2020 (actual)
- First posted
- 3 Oct 2018 (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 the PRELUDE BTK study is to assess safety and efficacy of the Serranator® PTA Serration Balloon Catheter (study device) in subjects with atherosclerotic peripheral artery disease of the infrapopliteal arteries.
Detailed description
Single arm, prospective, multi-center feasibility study enrolling up to 48 subjects with atherosclerotic lesions in the infrapopliteal arteries and/or Critical Limb Ischemia (CLI). The study will capture acute angiographic data to compare the pre-Serranator® inflation vs post inflation effects and will include 6 month clinical follow up.
The study population will consist of subjects with claudication or CLI, with de novo stenoses or non-stented restenotic or total occlusion lesions in infrapopliteal arteries having lesion length up to and including 12 cm in length and reference vessel diameter of 2.5 mm to 3.5 mm inclusive.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Single Arm, treated with Serranator | Other | Device: SerranatorSubjects treated with Serrantor |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (18 listed)
- Male or female of >18 years old.
- Women of child bearing potential must have a negative urine pregnancy test within 7 days of index procedure.
- Subject or subject's legal representative has been informed of the nature of the study, agrees to participate and comply with all follow-up visits and has signed the consent form.
- Subject is eligible for standard surgical repair in target limb if necessary.
- Subject has Rutherford Clinical Category 3, 4 or 5. Enrollment of Rutherford 3 will be limited to no more than 40% of total subjects.
Key exclusion criteria (34 listed)
- Rutherford Clinical Category 1, 2, or 6
- Evidence of aneurysm or acute thrombus in the target vessel.
- Subjects with previous bypass surgery in lower target extremity.
- Planned major amputation (above the ankle) of either limb.
- Subject has significant stenosis or occlusion of inflow tract not successfully treated (>30% residual stenosis and/or significant complication of the procedure).
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 |
|---|---|---|
| SerranatorThe Serranator® PTA Serration Balloon Catheter is an over-the-wire (OTW) balloon dilatation catheter designed to perform percutaneous transluminal angioplasty (PTA) for peripheral indications. | Device | Single Arm, treated with Serranator |
Primary outcome
Incidence of MALE and POD (Safety)
Time frame: 30 days post procedure
Composite of Major Adverse Limb Events (MALE) and Peri-procedural Death (POD), assessed at 30 days post procedure. MALE plus POD is defined as a composite of all cause death, thrombolysis/thrombectomy at the target lesion, open surgical revision or bypass, and major (above ankle) target limb amputation at 30 days post procedure. Safety will be evaluated on a per subject basis.
1 secondary outcome
Rate of Device Success (Procedural Efficacy)
Time frame: Immediately Post Serranator treatment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jan 2021.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
6 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Serranator in people with Peripheral Arterial Disease and Critical Limb Ischemia, run by Cagent Vascular LLC at 6 sites in 4 countries.
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 18 inclusion and 34 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: finished, as of the sponsor's last update on 28 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in Germany, Austria, New Zealand, Poland. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Incidence of MALE and POD (Safety) (time frame: 30 days post procedure). 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 28 Jan 2021.