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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT04525794




Registration number
NCT04525794
Ethics application status
Date submitted
13/08/2020
Date registered
25/08/2020
Date last updated
10/02/2021

Titles & IDs
Public title
BRight DCB First-in-Human Study
Scientific 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)
Secondary ID [1] 0 0
C1904
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 -


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
Late Lumen Loss - Late Lumen Loss, as measure by quantitative vascular angiography (QVA)
Timepoint [1] 0 0
6 months post index procedure
Secondary outcome [1] 0 0
Device success - Successful delivery, balloon inflation/deflation and retrieval of the intact trial device
Timepoint [1] 0 0
during procedure
Secondary outcome [2] 0 0
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
Timepoint [2] 0 0
during procedure
Secondary outcome [3] 0 0
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
Timepoint [3] 0 0
72 hours post index procedure
Secondary outcome [4] 0 0
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
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 - 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.
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 - 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.
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
Amputation (minor and major) rate - rate of amputation (minor and major)
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 - change in the Rutherford classification between baseline and follow-up
Timepoint [9] 0 0
1, 6 and 12 months post index procedure
Secondary outcome [10] 0 0
Change in resting target limb Ankle Brachial Index (ABI) as compared to baseline - change in ABI between baseline and follow-up
Timepoint [10] 0 0
1, 6 and 12 months post index procedure
Secondary outcome [11] 0 0
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
Timepoint [11] 0 0
1, 6 and 12 months post index procedure
Secondary outcome [12] 0 0
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)
Timepoint [12] 0 0
1, 6 and 12 months post index procedure
Secondary outcome [13] 0 0
Change in the Walking Impairment questionnaire (WIQ) as compared to baseline - change in WIQ between baseline and follow-up
Timepoint [13] 0 0
1, 6 and 12 months post index procedure
Secondary outcome [14] 0 0
Embolic event of the index limb - occurrence of embolic event as visualized on angiography
Timepoint [14] 0 0
during procedure, 1, 6 and 12 months post index 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. Rutherford-Becker Clinical Category of 2, 3 or 4

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

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

7. 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)

8. 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.

9. Successful guidewire crossing of lesion.

10. After pre-dilatation, the target lesion is = 30% residual stenosis with no flow
limiting dissection and treatable with a single balloon

11. Inflow artery is patent, free from significant lesion stenosis (>50% stenosis
considered significant) as confirmed by angiography.

12. 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.)
Minimum age
18 Years
Maximum age
No limit
Gender
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

3. Contraindication to dual anti-platelet therapy

4. Subject is receiving chronic anticoagulation therapy (e.g. low molecular weight
heparin, warfarin, or novel direct oral anticoagulants (N(D)OACs)).

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 prior to enrollment- contralateral iliac artery treatment
with no drug eluting technology is allowed during the index procedure)

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

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

15. Subject is receiving immunosuppressant therapy.

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

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

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

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

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

21. 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

22. 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)

23. Non femoral vascular access

24. Target lesion would require treatment with more than one balloon

25. Known inadequate distal outflow

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

27. Aneurysmal target vessel

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

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

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

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

32. 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
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Fiona Stanley Hospital - Perth
Recruitment hospital [2] 0 0
Royal Perth Hospital - Perth
Recruitment hospital [3] 0 0
Royal North Shore Hospital - Sydney
Recruitment postcode(s) [1] 0 0
- Perth
Recruitment postcode(s) [2] 0 0
- Sydney
Recruitment outside Australia
Country [1] 0 0
New Zealand
State/province [1] 0 0
Auckland

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Biotronik CRC Inc.
Address
Country
Other collaborator category [1] 0 0
Commercial sector/Industry
Name [1] 0 0
Biotronik AG
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
Brief 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.
Trial website
https://clinicaltrials.gov/show/NCT04525794
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 44 864 53 68
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/show/NCT04525794