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Peripheral Artery DiseaseNCT04525794

BRight DCB First-in-Human Study

A study testing BRight DCB in people with Peripheral Artery Disease, run by Biotronik CRC Inc. at 7 sites in 4 countries.

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

The primary aim of this clinical study is to assess the safety and clinical performance of the BRight drug-coated balloon (DCB) in the treatment of lower limb arteries stenosis in subjects with Peripheral Artery Disease (PAD). The primary endpoint will be Late Lumen Loss (LLL) of the target lesion at 6 months. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Peripheral Artery Disease
What is being tested?
BRight DCB
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
48 participants
Where
7 sitesin 4 countries
Study dates
4 Feb 2021to 2 Feb 2024
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

  • The subject has provided written informed consent
  • The subject is willing to participate in the clinical investigation and to comply with the study procedures and follow-up visits
  • Lifestyle-limiting claudication or rest pain requiring treatment of superficial femoral (SFA) and/or proximal popliteal artery (PPA)
  • Rutherford-Becker Clinical Category of 2, 3 or 4
  • Target vessel reference diameter ≥5 mm and ≤ 6 mm (by visual estimation)
  • De novo lesion with >50% stenosis by operator visual estimate within the SFA and/or proximal popliteal arteries in a single limb.
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  • Lesion must be located ≥ 1 cm below the Common Femoral Artery (CFA) bifurcation and terminate distally at ≥ 3 cm proximal to the knee joint (radiographic joint space)
  • Single lesion length ≤100 mm for de novo stenotic lesions, or ≤ 70 mm for occluded lesions (one long lesion or multiple serial lesions) by operator visual estimate. Note: Only 1 lesion per patient can be treated. Multiple serial lesions are allowed provided that they can be treated as a single lesion with one balloon.
  • Successful guidewire crossing of lesion.
  • After pre-dilatation, the target lesion is ≤ 30% residual stenosis with no flow limiting dissection and treatable with a single balloon
  • Inflow artery is patent, free from significant lesion stenosis (>50% stenosis considered significant) as confirmed by angiography.
  • Target limb with at least 1 patent (less than 50% stenosis) tibio-peroneal run-off vessel in the target limb confirmed at baseline. (Note: treatment of outflow disease is not permitted.)

Who cannot join

  • Females who are pregnant, lactating, or intended to become pregnant, or males intending to father children during the study
  • Subject under current medication known to affect CYP3A4 metabolism
  • Contraindication to dual anti-platelet therapy
  • Subject is receiving chronic anticoagulation therapy (e.g. low molecular weight heparin, warfarin, or novel direct oral anticoagulants (N(D)OACs)).
  • Known intolerance to study medications, Limus- like drug or contrast agents that in the opinion of the investigator could not be adequately pretreated
  • Current participation in an investigational drug or another device study
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  • History of hemorrhagic stroke within 3 months
  • Patients with a history of Myocardial Infarction (MI) or thrombolysis within 30 days prior-index procedure
  • Previous or planned surgical or interventional procedure within 14 days before or 30 days after index procedure (successful treatment of the ipsilateral and contralateral iliac arteries is permitted prior to enrollment- contralateral iliac artery treatment with no drug eluting technology is allowed during the index procedure)
  • Prior endovascular treatment of the target lesion (e.g., POBA, DCB, BMS, DES, cutting balloons, scoring balloons, cryoplasty, thrombectomy, atherectomy, brachytherapy or laser devices)
  • Previous placement of a bypass graft proximal to the target lesion
  • Chronic renal insufficiency (eGFR < 30 mL/min within 72 hours prior to index procedure)
  • No normal proximal arterial segment in which duplex ultrasound velocity ratios could be measured.
  • Subject is unable to walk without assistance (e.g. walker, cane).
  • 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 is unable to tolerate blood transfusions because of religious beliefs or other reasons.
  • Subject has history of gastrointestinal hemorrhage requiring a transfusion within 3 months prior to the index procedure.
  • Life expectancy less than 12 months due to other comorbidities, that in the investigators opinion, could limit subject ability to comply with the study required follow-up visits/procedure and threaten the study scientific integrity
  • Treatment of the contralateral limb during the same procedure or within 30 days following the study procedure (exclusive of the iliac arteries, which can be treated prior to enrollment or during the index procedure if no drug eluting technology is used)
  • Non femoral vascular access
  • Target lesion would require treatment with more than one balloon
  • Known inadequate distal outflow
  • Acute or sub-acute thrombus in the target vessel
  • Aneurysmal target vessel
  • Use of adjunctive therapies (i.e. laser, atherectomy, cryoplasty, scoring/cutting balloon, brachytherapy) during the study procedure in the target lesion or target vessel
  • Presence of concentric calcification that precludes PTA pre-dilatation
  • Significant contralateral or ipsilateral common femoral disease that requires intervention during the index procedure
  • Persistent hemodynamically-significant stenosis following predilatation or residual stenosis of >30%, stent placement, or flow-limiting (Grade D or greater) dissection following pre-dilatation
  • In-stent restenosis

Trial locations and contacts

7 sites in 4 countries.

7 sites in 4 countries

Australia4 sites

  • Fiona Stanley Hospital

    Perth

  • Royal Perth Hospital

    Perth

  • Prince of Wales Hospital

    Randwick, New South Wales, 2031

  • Royal North Shore Hospital

    Sydney

Other trials in Australia

Austria1 site

  • Medical University Graz

    Graz, Styria, 8036

Other trials in Austria

Germany1 site

  • Klinikum Hochsauerland

    Arnsberg, 59759

Other trials in Germany

New Zealand1 site

  • Auckland City Hospital

    Auckland

Other trials in New Zealand

About this study

Official title: BIOTRONIK- First-in-Human Assessment of the Safety and Clinical Performance of a Sirolimus Derivative-Coated Balloon (BRight DCB) in the Treatment of Subjects With de Novo Lesions in the Superficial Femoral and Proximal Popliteal Artery (BRight First Study)

The primary aim of this clinical study is to assess the safety and clinical performance of the BRight drug-coated balloon (DCB) in the treatment of lower limb arteries stenosis in subjects with Peripheral Artery Disease (PAD).

The primary endpoint will be Late Lumen Loss (LLL) of the target lesion at 6 months.

Being tested
BRight DCB
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.

  • BRight DCBDevice

    The BRight Drug-Coated Percutaneous Transluminal Angioplasty (PTA) Balloon catheter (BRight DCB) is intended for dilatation of de novo lesions in native superficial femoral or popliteal arteries with a simultaneous release of drug to the vessel wall as a secondary action to reduce occurrence of a restenosis of the treated vessel segment.

Study groups in NCT04525794
Study groupRoleWhat they receive
BRight DCBExperimentalNot described
Receives: Device: BRight DCB

What is being measured

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

  1. Late Lumen Loss

    Late Lumen Loss, as measure by quantitative vascular angiography (QVA)

    Measured: 6 months post index procedure

Secondary outcomes (14)

  1. Device success

    Successful delivery, balloon inflation/deflation and retrieval of the intact trial device

    Measured: during procedure

  2. Acute technical success

    Successful vascular access and completion of the endovascular procedure and immediate achievement of a final residual diameter stenosis of ≤30% of the treated lesion by core laboratory assessed QVA on the completion angiography with no bailout stenting

    Measured: during procedure

  3. Acute procedural success

    Technical success without the occurrence of death, major target limb amputation, thrombosis of the target lesion, or clinically-driven TLR within 72 hours of the index procedure

    Measured: 72 hours post index procedure

  4. Major Adverse Event (MAE) rate

    MAE is a composite of device or procedure related death within 30 days post index procedure, major index limb amputation, cd TLR

    Measured: 1, 6 and 12 months post index procedure

  5. Clinically-driven Target Lesion Revascularization (cd TLR) rate

    cd TLR is defined as any repeat intervention of the target lesions or surgical bypass of the target vessel performed for restenosis > 50% or other complication involving the target lesion, after documentation of recurrent clinical symptoms of the patient.

    Measured: 1, 6 and 12 months post index procedure

  6. Clinically-driven Target Vessel Revascularization (cd TVR) rate

    cd TVR, defined as any repeat percutaneous intervention or surgical bypass of any segment of the target vessel, after documentation of recurrent clinical symptoms of the patient.

    Measured: 1, 6 and 12 months post index procedure

  7. All-cause of death rate

    Measured: 1, 6 and 12 months post index procedure

  8. Amputation (minor and major) rate

    rate of amputation (minor and major)

    Measured: 1, 6 and 12 months post index procedure

  9. Change in Rutherford Classification as compared to baseline

    change in the Rutherford classification between baseline and follow-up

    Measured: 1, 6 and 12 months post index procedure

  10. Change in resting target limb Ankle Brachial Index (ABI) as compared to baseline

    change in ABI between baseline and follow-up

    Measured: 1, 6 and 12 months post index procedure

  11. Target lesion Binary Restenosis

    Defined as duplex ultrasound peak systolic velocity ratio (PSVR) > 2.5 (if DUS is completed) or angiographic assessment which suggests stenosis > 50% by QVA

    Measured: 1, 6 and 12 months post index procedure

  12. Target lesion primary patency

    Target lesion primary patency defined as duplex ultrasound peak systolic velocity ratio (PSVR) ≤ 2.5 (if DUS is completed) or angiographic assessment which suggests stenosis ≤ 50% by QVA and the absence of Clinically-driven TLR (adjudicated by a CEC)

    Measured: 1, 6 and 12 months post index procedure

  13. Change in the Walking Impairment questionnaire (WIQ) as compared to baseline

    change in WIQ between baseline and follow-up

    Measured: 1, 6 and 12 months post index procedure

  14. Embolic event of the index limb

    occurrence of embolic event as visualized on angiography

    Measured: during procedure

Timeline

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

  1. First posted25 Aug 2020
  2. Study start4 Feb 2021
  3. Primary completion20 Sep 2023
  4. Study completion2 Feb 2024

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
48 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04525794
Sponsor's protocol ID
C1904
Status last verified
May 2024
First submitted
13 Aug 2020
Last updated
22 May 2024
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing BRight DCB in people with Peripheral Artery Disease, run by Biotronik CRC Inc. at 7 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 12 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 22 May 2024. 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 Australia, Austria, Germany, 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?

Late Lumen Loss (time frame: 6 months post index procedure). 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 NCT04525794.

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 22 May 2024.

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