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Peripheral Artery DiseaseNCT06065345

BRight Pharmacokinetic Study

A study testing BRight DCB in people with Peripheral Artery Disease, run by Biotronik CRC Inc. at 1 site in Australia.

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 BRight PK Study is a prospective, single-arm, open-label, non-blinded, non-randomized study, which goal is to assess the pharmacokinetic profile of the BRight drug-coated balloon at different time points after the balloon deployment. The study will enroll a maximum of 10 patients at a single site in Australia 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
6 participants
Where
1 siteAustralia
Study dates
1 May 2024to 22 Jul 2025
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)
  • Age ≥ 18 years old
  • Rutherford-Becker Clinical Category of 2, 3 or 4
  • Target vessel reference diameter ≥5 mm and ≤ 6 mm (by visual estimation)
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  • De novo lesion with >50% stenosis by operator visual estimate within the SFA and/or proximal popliteal arteries in a single limb.
  • 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 ≤170 mm for de novo stenotic lesions, or ≤ 100 mm for occluded lesions (one long lesion or multiple serial lesions) by operator visual estimate. Notes: (1) Only 1 lesion per patient can be treated. Multiple serial lesions are allowed if they can be treated as a single lesion with a maximum of 2 balloons. (2) a non-occlusive lesion that includes a totally occluded segment along its length are eligible provided that the overall treated lesion length is ≤170 mm (with / or without an occluded segment not greater than 100 mm in length).
  • Successful guidewire crossing of lesion.
  • After pre-dilatation, the target lesion is ≤ 30% residual stenosis with no flow limiting dissection and treatable with a maximum of 2 balloons.
  • Inflow artery is patent, free from significant lesion stenosis (>50% stenosis considered significant) as confirmed by angiography.
  • Note: Where required, inflow iliac arteries (common and external iliac arteries only) must be successfully treated during the index procedure. Completion angiography must confirm successful treatment of inflow disease (≤50% residual stenosis, no distal embolization, and no Grade C or greater dissection) prior to pre-dilatation of the target lesion. Drug-eluting devices are not allowed for treatment of the occluded inflow iliac arteries.
  • Patency of the popliteal segments P2 and P3 with at least 1 patent infrapopliteal run-off vessel (that may have a stenosis of less than 50% not interfering with the outflow to the pedal arch) to the ankle in continuity with the native femoropopliteal artery, in the target limb confirmed at baseline. (Note: treatment of outflow disease is permitted. Drug-eluting devices are not allowed for outflow treatment)

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, or consuming food or beverages that are known substrates of CYP3A4
  • Contraindication to dual anti-platelet therapy
  • Subject receiving chronic anticoagulation therapy (e.g. low molecular weight heparin, warfarin, or novel direct oral anticoagulants (N(D)OACs)) if the treatment cannot be interrupted 48 hours prior to the procedure
  • 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 during the index procedure. Drug-eluting devices are not allowed for treatment of the occluded inflow iliac arteries)
  • 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)
  • Patient requiring renal replacement therapy
  • 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 during the index procedure if no drug eluting technology is used)
  • Non femoral vascular access
  • Target lesion would require treatment with more than two BRight balloons
  • 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

1 site in 1 country.

Australia1 site

  • Royal Perth Hospital

    Perth, WAUS

Other trials in Australia

About this study

Official title: BIOTRONIK- Pharmacokinetic Study of a Sirolimus Derivative-Coated Balloon (BRight DCB) in the Superficial Femoral and Proximal Popliteal Artery

The BRight PK Study is a prospective, single-arm, open-label, non-blinded, non-randomized study, which goal is to assess the pharmacokinetic profile of the BRight drug-coated balloon at different time points after the balloon deployment.

The study will enroll a maximum of 10 patients at a single site in Australia

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 NCT06065345
Study groupRoleWhat they receive
BRight DCBExperimentalSingle arm study. All subjects will be treated with the BRight DCB
Receives: Device: BRight DCB

What is being measured

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

  1. AUC 0-t

    Area under the drug concentration-time curve, calculated using linear trapezoidal summation from time zero to time tlast, where tlast is the time of the last measurable concentration (Ct).

    Measured: 0 to 24 hours

  2. AUC 0-inf

    Area under the drug concentration-time curve from time zero to infinity

    Measured: 0 to 24 hours

  3. Cmax

    Maximum observed drug concentration

    Measured: 0 to 24 hours

  4. Terminal Elimination Rate Constant (λz)

    Apparent terminal elimination rate constant, calculated by linear regression of the terminal linear portion of the log concentration vs. time curve

    Measured: 0 to 24 hours

  5. Terminal Elimination Half-life (t1/2)

    Apparent terminal elimination half-life, calculated as ln(2)/λz

    Measured: 0 to 24 hours

  6. tmax

    Time of the maximum drug concentration (obtained without interpolation). If the maximum value occurs at more than one time point, tmax is defined as the first time point with this value.

    Measured: 0 to 24 hours

  7. Drug clearance (CL)

    Apparent total clearance, calculated as dose/AUC0-inf

    Measured: 0 to 24 hours

  8. Apparent volume of distribution at the terminal phase (Vz)

    Apparent volume of distribution at the terminal phase, calculated as CL/λz

    Measured: 0 to 24 hours

  9. Metabolic Ratio (MR)

    Metabolic ratio calculated as the molar concentration of sirolimus AUC0-inf to BIOtorcin AUC0-inf

    Measured: 0 to 24 hours

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 procedure

  4. Major adverse event (MAE) rate

    MAE is a composite of device or procedure related death within 30 days post index procedure, or major index limb amputation, or cd TLR at 1, 6 and 12 months post index procedure

    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. Target limb major (above the ankle) and minor (below the ankle) amputation rate

    Measured: 1, 6 and 12 months post index procedure

  9. Change in Rutherford Classification as compared to baseline

    Measured: 1, 6 and 12 months post index procedure

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

    Measured: 1, 6 and 12 months post index procedure

  11. Change in Walking Impairment Questionnaire (WIQ) as compared to baseline

    Measured: 1, 6 and 12 months post index procedure

  12. Target lesion Binary Restenosis rate

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

    Measured: 1, 6 and 12 months post index procedure

  13. Target lesion Primary Patency rate

    Defined as duplex ultrasound peak systolic velocity ratio (PSVR) ≤ 2.5 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

  14. embolic event of the index limb rate

    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 posted3 Oct 2023
  2. Study start1 May 2024
  3. Primary completion27 Jun 2024
  4. Study completion22 Jul 2025

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
6 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06065345
Sponsor's protocol ID
C2304
Status last verified
Aug 2025
First submitted
18 Sep 2023
Last updated
5 Sep 2025
Results posted
No
Data monitoring committee
No
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 1 site in Australia.

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 14 inclusion and 33 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 5 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Australia. 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?

AUC 0-t (time frame: 0 to 24 hours). The study lists 9 primary outcomes in all. 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 NCT06065345.

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 5 Sep 2025.

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