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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT06065345




Registration number
NCT06065345
Ethics application status
Date submitted
18/09/2023
Date registered
3/10/2023
Date last updated
22/05/2024

Titles & IDs
Public title
BRight Pharmacokinetic Study
Scientific title
BIOTRONIK- Pharmacokinetic Study of a Sirolimus Derivative-Coated Balloon (BRight DCB) in the Superficial Femoral and Proximal Popliteal Artery
Secondary ID [1] 0 0
C2304
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Peripheral Artery Disease 0 0
Condition category
Condition code
Cardiovascular 0 0 0 0
Diseases of the vasculature and circulation including the lymphatic system

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Devices - BRight DCB

Experimental: BRight DCB - Single arm study. All subjects will be treated with the BRight DCB


Treatment: Devices: BRight DCB
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.
Intervention code [1] 0 0
Treatment: Devices
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
AUC 0-t
Timepoint [1] 0 0
0 to 24 hours
Primary outcome [2] 0 0
AUC 0-inf
Timepoint [2] 0 0
0 to 24 hours
Primary outcome [3] 0 0
Cmax
Timepoint [3] 0 0
0 to 24 hours
Primary outcome [4] 0 0
Terminal Elimination Rate Constant (?z)
Timepoint [4] 0 0
0 to 24 hours
Primary outcome [5] 0 0
Terminal Elimination Half-life (t1/2)
Timepoint [5] 0 0
0 to 24 hours
Primary outcome [6] 0 0
tmax
Timepoint [6] 0 0
0 to 24 hours
Primary outcome [7] 0 0
Drug clearance (CL)
Timepoint [7] 0 0
0 to 24 hours
Primary outcome [8] 0 0
Apparent volume of distribution at the terminal phase (Vz)
Timepoint [8] 0 0
0 to 24 hours
Primary outcome [9] 0 0
Metabolic Ratio (MR)
Timepoint [9] 0 0
0 to 24 hours
Secondary outcome [1] 0 0
Device success
Timepoint [1] 0 0
during procedure
Secondary outcome [2] 0 0
Acute technical success
Timepoint [2] 0 0
during procedure
Secondary outcome [3] 0 0
Acute procedural success
Timepoint [3] 0 0
72 hours post procedure
Secondary outcome [4] 0 0
Major adverse event (MAE) rate
Timepoint [4] 0 0
1, 6 and 12 months post index procedure
Secondary outcome [5] 0 0
Clinically-driven Target Lesion Revascularization (cd TLR) rate
Timepoint [5] 0 0
1, 6 and 12 months post index procedure
Secondary outcome [6] 0 0
Clinically-driven Target Vessel Revascularization (cd TVR) rate
Timepoint [6] 0 0
1, 6 and 12 months post index procedure
Secondary outcome [7] 0 0
All-cause of death rate
Timepoint [7] 0 0
1, 6 and 12 months post index procedure
Secondary outcome [8] 0 0
Target limb major (above the ankle) and minor (below the ankle) amputation rate
Timepoint [8] 0 0
1, 6 and 12 months post index procedure
Secondary outcome [9] 0 0
Change in Rutherford Classification as compared to baseline
Timepoint [9] 0 0
1, 6 and 12 months post index procedure
Secondary outcome [10] 0 0
Change in Ankle Brachial Index (ABI) as compared to baseline
Timepoint [10] 0 0
1, 6 and 12 months post index procedure
Secondary outcome [11] 0 0
Change in Walking Impairment Questionnaire (WIQ) as compared to baseline
Timepoint [11] 0 0
1, 6 and 12 months post index procedure
Secondary outcome [12] 0 0
Target lesion Binary Restenosis rate
Timepoint [12] 0 0
1, 6 and 12 months post index procedure
Secondary outcome [13] 0 0
Target lesion Primary Patency rate
Timepoint [13] 0 0
1, 6 and 12 months post index procedure
Secondary outcome [14] 0 0
embolic event of the index limb rate
Timepoint [14] 0 0
during procedure

Eligibility
Key inclusion criteria
1. The subject has provided written informed consent

2. The subject is willing to participate in the clinical investigation and to comply with
the study procedures and follow-up visits

3. Lifestyle-limiting claudication or rest pain requiring treatment of superficial
femoral (SFA) and/or proximal popliteal artery (PPA)

4. Age = 18 years old

5. Rutherford-Becker Clinical Category of 2, 3 or 4

6. Target vessel reference diameter =5 mm and = 6 mm (by visual estimation)

7. De novo lesion with >50% stenosis by operator visual estimate within the SFA and/or
proximal popliteal arteries in a single limb.

8. 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).

9. 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).

10. Successful guidewire crossing of lesion.

11. After pre-dilatation, the target lesion is = 30% residual stenosis with no flow
limiting dissection and treatable with a maximum of 2 balloons.

12. 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.

13. 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)
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Females who are pregnant, lactating, or intended to become pregnant, or males
intending to father children during the study

2. Subject under current medication known to affect CYP3A4 metabolism, or consuming food
or beverages that are known substrates of CYP3A4

3. Contraindication to dual anti-platelet therapy

4. 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

5. Known intolerance to study medications, Limus- like drug or contrast agents that in
the opinion of the investigator could not be adequately pretreated

6. Current participation in an investigational drug or another device study

7. History of hemorrhagic stroke within 3 months

8. Patients with a history of Myocardial Infarction (MI) or thrombolysis within 30 days
prior-index procedure

9. 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)

10. Prior endovascular treatment of the target lesion (e.g., POBA, DCB, BMS, DES, cutting
balloons, scoring balloons, cryoplasty, thrombectomy, atherectomy, brachytherapy or
laser devices)

11. Previous placement of a bypass graft proximal to the target lesion

12. Chronic renal insufficiency (eGFR < 30 mL/min within 72 hours prior to index
procedure)

13. Patient requiring renal replacement therapy

14. No normal proximal arterial segment in which duplex ultrasound velocity ratios could
be measured.

15. Subject is unable to walk without assistance (e.g. walker, cane).

16. Subject is receiving immunosuppressant therapy.

17. Subject has known or suspected active infection at the time of the index procedure.

18. Subject has platelet count < 100,000/mm3 or > 700,000/mm3.

19. Subject has white blood cell (WBC) count < 3,000/mm3.

20. Subject is unable to tolerate blood transfusions because of religious beliefs or other
reasons.

21. Subject has history of gastrointestinal hemorrhage requiring a transfusion within 3
months prior to the index procedure.

22. 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

23. 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)

24. Non femoral vascular access

25. Target lesion would require treatment with more than two BRight balloons

26. Known inadequate distal outflow

27. Acute or sub-acute thrombus in the target vessel

28. Aneurysmal target vessel

29. Use of adjunctive therapies (i.e. laser, atherectomy, cryoplasty, scoring/cutting
balloon, brachytherapy) during the study procedure in the target lesion or target
vessel

30. Presence of concentric calcification that precludes PTA pre-dilatation

31. Significant contralateral or ipsilateral common femoral disease that requires
intervention during the index procedure

32. Persistent hemodynamically-significant stenosis following predilatation or residual
stenosis of >30%, stent placement, or flow-limiting (Grade D or greater) dissection
following pre-dilatation

33. In-stent restenosis

Study design
Purpose of the study
Treatment
Allocation to intervention
N/A
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/05/2024
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
30/09/2025
Actual
Sample size
Target
10
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
WAU
Recruitment hospital [1] 0 0
Royal Perth Hospital - Perth
Recruitment postcode(s) [1] 0 0
- Perth

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Biotronik CRC Inc.
Address
Country

Ethics approval
Ethics application status

Summary
Brief 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
Trial website
https://clinicaltrials.gov/ct2/show/NCT06065345
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Helene KUISSU
Address 0 0
Country 0 0
Phone 0 0
+41(0)798082147
Fax 0 0
Email 0 0
helene.kuissu@biotronik.com
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT06065345