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Peripheral Artery DiseaseNCT03638115

The VaSecure BTK Study

A study testing VaSecure™ in people with Peripheral Artery Disease and Peripheral Vascular Disease, run by Vascuros Medical Pte Ltd at 7 sites in 3 countries.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

To assess the safety and performance of the VaSecure drug-coated PTA balloon catheter in the treatment of patients with Chronic Limb Threatening Ischemia (CLTI) of the lower limb below the knee (BTK) Read more about this study

Who is it for?
Ages 21 to 90 years
What is being tested?
VaSecure™
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
46 participants
Where
7 sitesin 3 countries
Study dates
30 Oct 2018to 30 Jun 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 21 to 90 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Able to provide written informed consent prior to participating in the clinical investigation, e.g. patients are mentally able to understand the aim of the clinical investigation.
  • Has a documented diagnosis of CLTI of Rutherford category 3-5.
  • The target lesion must be de novo.
  • Life expectancy is >1 year, in the investigator's opinion.
  • For women: menopausal or under active birth control.
  • Patient must agree not to participate in any other clinical trial during 12 month follow-up period.
  • Visual angiographic inclusion criteria
  • Reference vessel(s) diameter is between 2mm-4mm. Each lesion in one or maximum two of the infrapopliteal arteries NOT extending beyond the ankle joint. Target lesion(s) consisting of a single solitary or series of multiple adjacent lesions (all less than 30 mm apart) in a single tibial vessel with a diameter stenosis ≥70% and a cumulative length of ≥50 mm to ≤250 mm. If there are two target lesions they will be separated for ≥3 cm and will be named from proximal to distal. Target lesion must be a tibial vessel (excluding popliteal artery) branching from popliteal artery.

Who cannot join

  • Breastfeeding or pregnant woman.
  • Severe concentric calcification, documented by angiography using the COMPLIANCE360-Score (This scoring system takes into account both the arc of calcium (< or > 180º) and percent of lesion length (< or > 50%) as judged by fluoroscopy.) that could not be fully expanded by predilatation balloon and documented by angiography. Valid record up to 30 days before screening.
  • Patients with major amputations that have already been performed or are planned, either on the target leg or on the contralateral side. .
  • History of stroke within 3 months.
  • History of myocardial infarction, thrombolysis or angina within 30 days prior to index procedure.
  • Renal failure or chronic kidney disease with estimated Glomerular Filtration Rate (eGFR) ≤30 mL/min per 1.73 m2 (or serum creatinine ≥2.5 mg/dL within 30 days of index procedure or treated with dialysis).
Show all 22Show fewer
  • Diagnosed active untreated systemic infection or uncontrolled coagulopathy within 14 days prior to index procedure.
  • Co-morbid conditions limiting life expectancy to <12 months.
  • Hemorrhagic diathesis or another disorder such as gastrointestinal ulceration or cerebral circulatory disorders which restrict the use of platelet aggregation inhibitor therapy and anticoagulation therapy.
  • Known allergy to paclitaxel or paclitaxel-related compounds or contrast media that cannot be adequately managed with pre- and post-procedure medication.
  • Is currently participating in an investigational drug or other investigational device study or previously enrolled in this study.
  • Is unlikely to comply with the follow up schedule.
  • Has uncontrolled ulcer wound infection.
  • Is unwilling to comply with a concurrent ulcer wound therapy.
  • Has an allergy to acetylsalicylic acid, prasugrel, ticagrelol, and clopidogrel (Plavix®).
  • Use of atherectomy in proximal vessels or TL. However, the use of scoring/cutting balloons in the TL is allowed.
  • Angiographic exclusion criteria
  • Lesions that cannot be successfully predilated to achieve a residual stenosis of <50% by visual estimate.
  • Severe dissection post dilatation resulting in a flow limiting lesion.
  • Thrombus in the target vessel documented by angiography.
  • Aneurysm in the target vessel(s).
  • Treatment of the contralateral limb during the same index procedure or within 30 days post-index procedure in order to avoid confounding complications.

Trial locations and contacts

7 sites in 3 countries.

Anthony Lie contact

+6569096493

a.lie@vascuros.com

7 sites in 3 countries

Germany3 sites, 3 recruiting

  • Klinikum Hoschsauerland

    Arnsberg

    Michael Lichtenberg, MD

    Not yet recruiting

  • Universitaetsklinikum Muenster

    Münster

    Nasser Malyar, MD

    Not yet recruiting

  • Regiomed Kliniken Sonneberg

    Sonneberg

    Marcus Thieme, MD

    Not yet recruiting

Other trials in Germany

Belgium2 sites, 2 recruiting

  • Ziekenhuis Oost Limburg

    Genk

    Wouter Lansink, MD

    Not yet recruiting

  • Regionaal Ziekenhuis Heilig Hart

    Tienen

    Koen Keirse, MD

    Not yet recruiting

Other trials in Belgium

Singapore2 sites, 2 recruiting

  • Changi General Hospital

    Singapore

    Yih Kai Tan, MD

    Recruiting

  • National University Hospital

    Singapore

    Pei Ho, MD

    Recruiting

Other trials in Singapore

About this study

Official title: Clinical Investigation of the Safety & Effectiveness of the VaSecure 018 Drug Coated PTA Balloon Catheter in the Treatment of Patients With Chronic Limb Threatening Ischemia (CLTI) Involving Below-the-Knee (BTK) Arteries

To assess the safety and performance of the VaSecure drug-coated PTA balloon catheter in the treatment of patients with Chronic Limb Threatening Ischemia (CLTI) of the lower limb below the knee (BTK)

Read the detailed description

The VaSecure Drug Coated PTA Balloon Catheter is indicated for percutaneous transluminal angioplasty (PTA), after predilatation, of de novo lesions in the peripheral vasculature of the lower limb with reference vessel diameters of 2-4 mm.

The study will include patients with lesions located in the infrapopliteal arteries diagnosed with CLTI of Rutherford categories 3-5. A maximum number of 46 patients will be enrolled in this clinical investigation in 7 sites in Europe and 2 in Singapore.

Being tested
VaSecure™
Medical subject headings
Peripheral Arterial Disease, Peripheral Vascular Diseases, Peripheral Arterial Occlusive Disease 1

What participants receive

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

  • VaSecure™Device

    Drug Coated PTA Balloon Catheter

Study groups in NCT03638115
Study groupRoleWhat they receive
VaSecure™ Drug Coated PTA Balloon CatheterExperimentalNot described
Receives: Device: VaSecure™

What is being measured

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

  1. Freedom from a composite endpoint of Major adverse limb event (MALE) and procedure-related mortality.

    Major adverse limb event is defined as the composite of either major amputation or major re-intervention through 30 days of the index procedure.

    Measured: 30 days

Secondary outcomes (15)

  1. Procedure success rate

    Composite of technical success defined as successful vascular access and completion of the endovascular procedure as well as immediate morphological success with <30% residual reduction in diameter as assessed by QVA and Device success defined as exact deployment of the device according to the Instructions For Use (IFU) as documented by suitable imaging means

    Measured: Index procedure or 1 day post index procedure

  2. Incidence of all Adverse Events (AEs)

    All AEs will be characterized by severity, relatedness, outcome and treatment

    Measured: 30 days, and 3, 6, 9 and 12 months

  3. Freedom from major target limb amputation

    Rates of amputation of the lower limb above 1 cm from the ankle mortice/joint upwards

    Measured: 3, 6, 9 and 12 months

  4. Freedom from clinically-driven target lesion revascularization (cd-TLR) and target vessel revascularization (TVR)

    Clinically-driven TLR is defined by core lab confirmation of restenosis ≥70% in the target lesion with wound persistence, new wounds or re-occurence of ischemic rest pain

    Measured: 3, 6, 9 and 12 months

  5. Late Lumen Loss (LLL) of the target lesion

    As measured by QVA

    Measured: 6 months

  6. Angiographic Restenosis

    Defined as ≥70% diameter stenosis on 2-view angiography by visual estimate

    Measured: 6 months

  7. Angiographic Restenotic Burden

    Defined as the percentage of length of stenosis/occlusion ≥70% on 2-view angiography by visual estimate in mm, divided by the total length of the lesion in mm

    Measured: 6 months

  8. Freedom from occlusion (FFO) without cd-TLR on Duplex ultrasound

    Defined as presence of flow on colour doppler of the target lesion

    Measured: 3, 6 and 9 months

  9. Haemodynamic microvascular performance

    As measured by transcutaneous oxygen (TcpO2)

    Measured: Baseline, 3, 6 and 12 months

  10. Haemodynamic microvascular performance

    As measured by Ankle-Brachial-Index (ABI).

    Measured: Baseline, 6 and 12 months

  11. Wound healing rate

    Defined as healed or not, if not, improving, stagnant or worsening

    Measured: 30 days, 3, 6, 9 and 12 months.

  12. Rutherford status

    Change in Rutherford classification as assessed by the investigator

    Measured: 3, 6, 9 and 12 months

  13. Clinical Improvement (combined endpoint) in amputation free, cd-TLR free, surviving patients

    Specified as an improvement shift in the Rutherford classification of one class.

    Measured: 3, 6, 9 and 12 months

  14. Limb salvage

    Defined as preservation of a functional foot without the need for a leg prosthesis

    Measured: 6 and 12 months

  15. Amputation-free survival

    Defined as composite endpoint of mortality and amputation

    Measured: 6 and 12 months

Timeline

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

  1. First posted20 Aug 2018
  2. Study start30 Oct 2018 (estimated)
  3. Primary completion1 Jun 2019 (estimated)
  4. Study completion30 Jun 2020 (estimated)

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
46 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03638115
Sponsor's protocol ID
SEC-BTK-001
Status last verified
Oct 2018
First submitted
10 Aug 2018
Last updated
26 Oct 2018
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A study testing VaSecure™ in people with Peripheral Artery Disease and Peripheral Vascular Disease, run by Vascuros Medical Pte Ltd at 7 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 8 inclusion and 22 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: status not confirmed, as of the sponsor's last update on 26 Oct 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 7 sites in Germany, Belgium, Singapore. 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?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Anthony Lie (+6569096493, a.lie@vascuros.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Freedom from a composite endpoint of Major adverse limb event (MALE) and procedure-related mortality. (time frame: 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 NCT03638115.

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 Oct 2018.

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