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Trial details imported from ClinicalTrials.gov

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




Registration number
NCT04525794
Ethics application status
Date submitted
13/08/2020
Date registered
25/08/2020

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
Timepoint [1] 0 0
6 months post index procedure
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 index 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
Amputation (minor and major) 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 resting target limb 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
Target lesion Binary Restenosis
Timepoint [11] 0 0
1, 6 and 12 months post index procedure
Secondary outcome [12] 0 0
Target lesion primary patency
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
Timepoint [13] 0 0
1, 6 and 12 months post index procedure
Secondary outcome [14] 0 0
Embolic event of the index limb
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. 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
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
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
NA
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
NA
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
4/02/2021
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
2/02/2024
Sample size
Target
Accrual to date
Final
48
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 0 0
Prince of Wales Hospital - Randwick
Recruitment hospital [2] 0 0
Fiona Stanley Hospital - Perth
Recruitment hospital [3] 0 0
Royal Perth Hospital - Perth
Recruitment hospital [4] 0 0
Royal North Shore Hospital - Sydney
Recruitment postcode(s) [1] 0 0
2031 - Randwick
Recruitment postcode(s) [2] 0 0
- Perth
Recruitment postcode(s) [3] 0 0
- Sydney
Recruitment outside Australia
Country [1] 0 0
Austria
State/province [1] 0 0
Styria
Country [2] 0 0
Germany
State/province [2] 0 0
Arnsberg
Country [3] 0 0
New Zealand
State/province [3] 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
Trial website
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
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT04525794