Peripheral Arterial DiseasePRELUDENCT03001700
PRospective Study for the TrEatment of Atherosclerotic Lesions in the Superficial Femoral and/or Popliteal Arteries Using the Serranator DevicE
A study testing Serranator™ Alto PTA Serration Balloon Catheter in people with Peripheral Arterial Disease, run by Cagent Vascular LLC at 4 sites in 3 countries.
Trial summary
To assess preliminary safety and efficacy of the Serranator™ Alto PTA Serration Balloon Catheter in subjects with atherosclerotic peripheral artery disease of the superficial femoral and popliteal arteries. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Peripheral Arterial Disease
- What is being tested?
- Serranator™ Alto PTA Serration Balloon Catheter
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 4 sitesin 3 countries
- Study dates
- 1 Feb 2017to 31 Dec 2017
- 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 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.
- Resting ABI -< 0.9.
- Subject is eligible for standard surgical repair in target limb if necessary.
- Subject has Rutherford Clinical Category 2,3, or 4
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- Estimated life expectancy > 1 year.
- Angiographic Inclusion Criteria:
- Lesion(s) located within the SFA and or popliteal arteries.
- Target lesion(s) has stenosis >70% by visual assessment.
- Reference vessel diameter is between 4.0mm and 6.0mm, inclusive.
- One long or multiple serial lesions that are up to 10 cms, (total occlusions up to 6cm) in length that can be covered by a single balloon.
- De-novo, or non-stented re-stenotic lesions
- At least one below the knee artery patent to the ankle.
- Successful treatment of iliac inflow stenosis to the target limb. Stenosis can be treated during the same procedure using standard angioplasty 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, 5 or 6.
- Previously implanted ipsilateral femoral or popliteal stent.
- 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).
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- History of any open surgical procedure within the past 30 days.
- Planned endovascular or vascular surgery procedure within 14 days prior to the ATK procedure, except to treat the inflow vessels on the day of the procedure, or within the next 30 days after the ATK procedure on the target limb.
- 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.
- Angiographic Exclusion Criteria:
- Chronic Total Occlusions (CTO) > 6cm in length
- Acute Total Occlusions; evidence of acute thrombus formation by angiography
- Severe calcification of target lesion described as circumferential calcium and >50% of lesion length.
- Sub-intimal access required
- Inability to cross the lesion with a guidewire
- Atherectomy in the target lesion, target artery or for inflow treatment
Trial locations and contacts
4 sites in 3 countries.
4 sites in 3 countries
Poland2 sites
Polsko-Amerykańskie Kliniki Serca PAKS Małopolskie Centrum Sercowo Naczyniowe
Chrzanów, 32-050
Szpital Uniwersytecki w Krakowie Pracownia Angiografii Oddział Angiologii
Krakow, 31-066
About this study
Official title: PRospective Study for the TrEatment of Atherosclerotic Lesions in the Superficial Femoral and/or Popliteal Arteries Using the Serranator DevicE: PRELUDE Study
To assess preliminary safety and efficacy of the Serranator™ Alto PTA Serration Balloon Catheter in subjects with atherosclerotic peripheral artery disease of the superficial femoral and popliteal arteries.
Read the detailed description
Single Arm, prospective, OUS multi-center feasibility study enrolling up to 30 subjects with superficial femoral or popliteal lesions. The study will capture acute angiographic data to compare the pre- Serranator™ inflation vs post inflation effects.
The study population will consist of subjects with claudication or ischemic rest pain, with de novo or non-stented restenotic lesions in femoropopliteal arteries having lesion length less than or equal to 10 cm, total occlusion up to 6 cms in length and reference vessel diameter of 4 mm to 6 mm, inclusive.
- Conditions
- Peripheral Arterial Disease
- Being tested
- Serranator™ Alto PTA Serration Balloon Catheter
- 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™ Alto PTA Serration Balloon CatheterDevice
The Serranator™ 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 |
|---|---|---|
| Treatment | Experimental | Subjects will be treated with the Serranator™ Alto PTA Serration Balloon Catheter device Receives: Device: Serranator™ Alto PTA Serration Balloon Catheter |
What is being measured
The primary outcome is the main question the study is designed to answer.
To evaluate the technical feasibility of using the Serranator™ Alto PTA Serration Balloon Catheter during the endovascular treatment of critical SFA or popliteal artery lesions.
Measured: Through Study Completion, approximately 6 months
Secondary outcomes (1)
OCT and/or IVUS imaging post use of the Serranator to document evidence of vessel wall serrations in a sub-set of up to 10 subjects.
Measured: Through Study Completion, approximately 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Dec 2016 (estimated)
- Study start1 Feb 2017
- Primary completion31 May 2017
- Study completion31 Dec 2017
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
- 25 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
- NCT03001700
- Sponsor's protocol ID
- CSP-0109
- Acronym
- PRELUDE
- Status last verified
- Apr 2018
- First submitted
- 16 Dec 2016
- Last updated
- 24 Apr 2018
- 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 24 Apr 2018. 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 Superficial Femoral and/or Popliteal Arteries Using the Serranator DevicE: PRELUDE Study
- ClinicalTrials.gov ID
- NCT03001700
- Acronym / sponsor ID
- PRELUDE / CSP-0109
- Conditions
- Peripheral Arterial Disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Cagent Vascular LLCIndustry (pharma, biotech, devices)
- Study start
- 1 Feb 2017 (actual)
- Primary completion
- 31 May 2017 (actual)
- Study completion
- 31 Dec 2017 (actual)
- First posted
- 23 Dec 2016 (estimated)
- 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.
To assess preliminary safety and efficacy of the Serranator™ Alto PTA Serration Balloon Catheter in subjects with atherosclerotic peripheral artery disease of the superficial femoral and popliteal arteries.
Detailed description
Single Arm, prospective, OUS multi-center feasibility study enrolling up to 30 subjects with superficial femoral or popliteal lesions. The study will capture acute angiographic data to compare the pre- Serranator™ inflation vs post inflation effects.
The study population will consist of subjects with claudication or ischemic rest pain, with de novo or non-stented restenotic lesions in femoropopliteal arteries having lesion length less than or equal to 10 cm, total occlusion up to 6 cms in length and reference vessel diameter of 4 mm to 6 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 |
|---|---|---|
| Treatment | Experimental | Device: Serranator™ Alto PTA Serration Balloon CatheterSubjects will be treated with the Serranator™ Alto PTA Serration Balloon Catheter device |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- Male or female of >18 years old.
- Women of child bearing potential must have a negative 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.
- Resting ABI -< 0.9.
- Subject is eligible for standard surgical repair in target limb if necessary.
Key exclusion criteria (32 listed)
- Rutherford Clinical Category 1, 5 or 6.
- Previously implanted ipsilateral femoral or popliteal stent.
- 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.
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™ Alto PTA Serration Balloon CatheterThe Serranator™ is an over-the-wire (OTW) balloon dilatation catheter designed to perform percutaneous transluminal angioplasty (PTA) for peripheral indications. | Device | Treatment |
Primary outcome
To evaluate the technical feasibility of using the Serranator™ Alto PTA Serration Balloon Catheter during the endovascular treatment of critical SFA or popliteal artery lesions.
Time frame: Through Study Completion, approximately 6 months
1 secondary outcome
OCT and/or IVUS imaging post use of the Serranator to document evidence of vessel wall serrations in a sub-set of up to 10 subjects.
Time frame: Through Study Completion, approximately 6 months
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 24 Apr 2018.
- 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.
4 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Serranator™ Alto PTA Serration Balloon Catheter in people with Peripheral Arterial Disease, run by Cagent Vascular LLC at 4 sites in 3 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 15 inclusion and 32 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 24 Apr 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Poland, Austria, New Zealand. 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?
To evaluate the technical feasibility of using the Serranator™ Alto PTA Serration Balloon Catheter during the endovascular treatment of critical SFA or popliteal artery lesions. (time frame: Through Study Completion, approximately 6 months). 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 24 Apr 2018.