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Peripheral Arterial DiseasePREVEILNCT02648620

Safety and Feasibility of SurModics SurVeil (TM) Drug Coated Balloon

A study testing SurVeil Drug Coated Balloon and Angioplasty in people with Peripheral Arterial Disease and Peripheral Vascular Diseases, run by SurModics, Inc. at 3 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

PREVEIL is a prospective, multi-center, single-arm clinical trial to assess the safety and functionality of the SurModics drug coated balloon (DCB) in the treatment of subjects with symptomatic peripheral artery disease (PAD) due to de novo stenoses of the femoral and popliteal arteries. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
SurVeil Drug Coated Balloon and Angioplasty
Could I receive a placebo?
No, everyone receives an active treatment
How many people
13 participants
Where
3 sitesUnited States
Study dates
5 Apr 2016to 11 Feb 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

  • Subjects must meet all of the following criteria to participate in the trial:
  • Subject is ≥ 18 years.
  • Subject has lifestyle-limiting claudication or rest pain with Rutherford classification 2, 3 or 4.
  • Subject has provided written informed consent.
  • Subject is willing to comply with study follow-up requirements.
  • A de novo target lesion in the femoral or popliteal arteries.
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  • Target lesion must have angiographic evidence of ≥ 50% stenosis by operator visual estimate.
  • Target lesion must be ≤ 90 mm in length (one long lesion or multiple serial lesions) by operator visual estimate. Note: Multiple serial lesions are allowed provided that they can be treated as a single lesion with one balloon.
  • Target vessel must have an reference vessel diameter (RVD) of 4 mm to 6 mm by operator visual estimate.
  • After pre-dilatation, the target lesion is ≤ 70% residual stenosis, absence of a flow limiting dissection and treatable with a single balloon (lesion length ≤90 mm, limited to 100-mm balloon in EFS).
  • A patent inflow artery free from significant stenosis (≥ 50% stenosis) as confirmed by angiography.
  • At least one patent native outflow artery to the ankle or foot, free from significant stenosis (≥ 50% stenosis) as confirmed by angiography.

Who cannot join

  • Subjects will be excluded from the trial if any of the following criteria are met:
  • Subject has acute limb ischemia.
  • Subject has Rutherford classification of 0, 1, 5 or 6.
  • Subject previously underwent any lower extremity percutaneous transluminal angioplasty (PTA) using a DCB within 3 months.
  • Subject has had prior vascular intervention within 2 weeks before the planned study index procedure or subject has planned vascular intervention within 30 days after the study index procedure.
  • Subject is pregnant and/or breast-feeding or intends to become pregnant during the time of the study OR subject is a male intending to father children within 60 days of index procedure.
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  • Life expectancy less than 2 years.
  • Subject has a known allergy to contrast medium that cannot be adequately pre-medicated.
  • Subject is allergic to ALL antiplatelet treatments.
  • Subject has impaired renal function (i.e. serum creatinine level ≥ 2.5 mg/dl).
  • Subject is dialysis dependent.
  • Subject is receiving immunosuppressant therapy.
  • Subject has known or suspected active infection at the time of the index procedure.
  • Subject has platelet count < 100,000/mm3 or > 700,000/mm3.
  • Subject has white blood cell (WBC) count < 3,000/mm3.
  • Subject has history of gastrointestinal hemorrhage requiring a transfusion within 3 months prior to the index procedure.
  • Subject is diagnosed with coagulopathy that precludes treatment with systemic anticoagulation and/or dual antiplatelet therapy (DAPT).
  • Subject is unable to tolerate blood transfusions because of religious beliefs or other reasons.
  • Subject is unwilling or unable to comply with procedures specified in the protocol or has difficulty or inability to return for follow-up visits as specified by the protocol.
  • Subject is known to be incarcerated, mentally incompetent and/or an alcohol or drug abuser.
  • Subject is participating in another investigational drug or medical device study that has not completed primary endpoint(s) evaluation or that clinically interferes with the endpoints from this study, or subject is planning to participate in such studies prior to the completion of this study.
  • Subject has had major surgical or interventional procedures unrelated to this study within 30 days prior to this study or has planned surgical or interventional procedures within 30 days of entry into this study.
  • Previous intervention at the lesion site including previous stenting within 3 cm of the target lesion or previous bypass surgery of the target lesion.
  • Previous treatment of the target vessel with thrombolysis or surgery.
  • Severe concentric calcification of the target lesion.
  • Target lesion involves an aneurysm or is adjacent to an aneurysm.
  • Target lesion requires treatment with alternative therapy such as stenting, laser, atherectomy, cryoplasty, brachytherapy or re-entry devices.
  • Significant vessel tortuosity or other parameters prohibiting access to the target lesion.
  • Presence of thrombus in the target vessel.
  • Iliac inflow disease requiring treatment , unless the iliac artery disease is successfully treated first during the index procedure. Success is defined as ≤ 30% residual diameter stenosis without death or major complications.
  • Absence of at least one patent native outflow artery.
  • Presence of an aortic, iliac or femoral artificial graft.
  • Failure to cross the target lesion with a guide wire. Successful crossing of the target lesion occurs when the tip of the guide wire is distal to the target lesion without the occurrence of flow-limiting dissection or perforation.
  • Failure to successfully pre-dilate the target lesion. Successful pre-dilatation is defined as residual stenosis ≤ 70% with no flow-limiting dissection.

Trial locations and contacts

3 sites in 1 country.

United States3 sites

  • OhioHealth Research Institute

    Columbus, Ohio, 43214

  • Wellmont Health System

    Kingsport, Tennessee, 37660

  • NC Heart and Vascular Research

    Raleigh, North Carolina, 27607

Other trials in United States

About this study

Official title: A Prospective, Multi-Center, Single-Arm Trial to Assess the Safety and Feasibility of the SurModics Drug Coated Balloon in the Treatment of Subjects With De Novo Lesions of the Femoropopliteal Artery

PREVEIL is a prospective, multi-center, single-arm clinical trial to assess the safety and functionality of the SurModics drug coated balloon (DCB) in the treatment of subjects with symptomatic peripheral artery disease (PAD) due to de novo stenoses of the femoral and popliteal arteries. The trial will enroll up to 15 subjects.

Read the detailed description

PREVEIL will enroll patients presenting with angiographic evidence of significant stenosis in the femoral or popliteal arteries. All enrolled subjects will be treated with the SurVeil DCB.

Being tested
SurVeil Drug Coated Balloon, Angioplasty
Keywords
Paclitaxel, Percutaneous Transluminal Angioplasty, PAD, Peripheral Artery Disease, Pharmacokinetics
Medical subject headings
Peripheral Arterial Disease, Peripheral Vascular Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • SurVeil Drug Coated BalloonDevice

    Also called SurModics SurVeil

    Angioplasty procedure with the SurModics SurVeil Paclitaxel-Coated, Percutaneous Transluminal Angioplasty (PTA) Balloon Catheter (Paclitaxel-coated PTA Catheter)

  • AngioplastyProcedure or surgery

    Also called SurModics SurVeil

    Angioplasty procedure with the SurModics SurVeil Paclitaxel-Coated, Percutaneous Transluminal Angioplasty (PTA) Balloon Catheter (Paclitaxel-coated PTA Catheter)

Study groups in NCT02648620
Study groupRoleWhat they receive
SurVeil Drug Coated Balloon catheterExperimentalPaclitaxel Coated Balloon catheter for angioplasty
Receives: Device: SurVeil Drug Coated Balloon; Procedure: Angioplasty

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Peak paclitaxel plasma concentration

    Paclitaxel plasma levels will be assessed at baseline, immediately post-index procedure, at 1h, 2h, 4h, 12h (or upon discharge), and 30 days post-index procedure.

    Measured: Up to 30 days

Secondary outcomes (22)

  1. Area under the drug concentration time curve

    Area under the drug concentration time curve from the time of intervention to the time where the paclitaxel level is no longer quantifiable will be measured. Paclitaxel plasma levels will be assessed at baseline, immediately post-index procedure, at 1h, 2h, 4h, 12h(or upon discharge), and 30 days post-index procedure.

    Measured: Up to 30 days

  2. Technical success

    Technical success, defined as successful delivery, inflation, deflation and retrieval of the intact study balloon device.

    Measured: At procedure

  3. Device success

    Device success, defined as achievement of < 50% residual stenosis of the target lesion (by core lab assessed quantitative angiography (QA)) using only the study device.

    Measured: At procedure

  4. Procedure success

    Procedure success, defined as achievement of < 50% residual stenosis of the target lesion (by core lab assessed QA) using the study device with or without the use of additional devices, without the occurrence of death, amputation or repeat revascularization of the target vessel during index hospital stay.

    Measured: At procedure up to 12 hours

  5. Resting ankle brachial index

    Measured: within 90 days of index procedure, and at 6, 12, 24 and 36 months post-index procedure

  6. Change in Rutherford classification

    Measured: baseline, 30 days, 6, 12, 24, and 36 months

  7. Change in 6-minute walk test

    Measured: baseline, 30 days, 6, 12, 24, and 36 months

  8. Primary patency

    defined as freedom from clinically-driven target lesion revascularization (TLR) and freedom from restenosis. Restenosis is defined by Duplex Ultrasound (DUS) peak systolic velocity ratio (PSVR) ≥ 2.5 (core lab assessed) or by ≥ 50% stenosis by QA (core lab assessed)

    Measured: 6 months

  9. Continuous DUS Peak systolic velocity ratio (PSVR) as measured by Duplex ultrasound

    Measured: 30 days, 6, 12, 24, and 36 months

  10. Late lumen loss

    Defined as the difference in minimum luminal diameter of the target lesion between the index intervention and 6-month angiographic follow-up.

    Measured: baseline, 6 months

  11. Quality of life

    Assessed by Change in walking Impairment Questionnaire (WIQ) scores

    Measured: baseline, 30 days, 6, 12, 24, and 36 months

  12. Evidence of Paclitaxel toxicity

    Evidence of paclitaxel toxicity (rash, myelosuppression on blood counts, hepatitis, neuromuscular changes, hypotension, electrocardiogram (ECG) abnormalities, or gastrointestinal upset).

    Measured: At hospital discharge, 30 days

  13. Major vascular complications

    Measured: At hospital discharge, 30 days

  14. Thrombolysis in Myocardial Infarction (TIMI)-defined major and minor bleeding

    Measured: At hospital discharge, 30 days

  15. Major adverse events

    defined as a composite of death, index limb amputation and TLR

    Measured: 30 days, 6, 12, 24, and 36 months

  16. All-cause death

    Measured: 30 days, 6, 12, 24, and 36 months

  17. Index limb above the ankle amputation

    Measured: 30 days, 6, 12, 24, and 36 months

  18. Index limb below the ankle amputation

    Measured: 30 days, 6, 12, 24, and 36 months

  19. Clinically-driven TLR

    Measured: 30 days, 6, 12, 24, and 36 months

  20. Clinically-driven target vessel revascularization (TVR)

    Measured: 30 days, 6, 12, 24, and 36 months

  21. Arterial thrombosis of the treated segment on angiography

    Measured: 30 days, 6, 12, 24, and 36 months

  22. Embolic events of the index limb

    Measured: 30 days, 6, 12, 24, and 36 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 Jan 2016 (estimated)
  2. Study start5 Apr 2016
  3. Primary completionJan 2017
  4. Study completion11 Feb 2020

Resources

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
13 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02648620
Sponsor's protocol ID
SUR15-001
Acronym
PREVEIL
Status last verified
Jul 2022
First submitted
18 Dec 2015
Last updated
26 Jul 2022
Results posted
No
Data monitoring committee
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

A study testing SurVeil Drug Coated Balloon and Angioplasty in people with Peripheral Arterial Disease and Peripheral Vascular Diseases, run by SurModics, Inc. at 3 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 12 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 26 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 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?

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?

Peak paclitaxel plasma concentration (time frame: Up to 30 days). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02648620.

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 26 Jul 2022.

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