BRight DCB First-in-Human Study

NCT ID: NCT04525794

Last Updated: 2024-05-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 48 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-02-04
• Study Completion Date: 2024-02-02

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.

Conditions

Peripheral Artery Disease

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

BRight DCB

Group Type: EXPERIMENTAL

BRight DCB

Intervention Type: DEVICE

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.

Interventions

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 Type: DEVICE

Eligibility Criteria

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.)

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Biotronik AG

INDUSTRY

Sponsor Role: collaborator

Biotronik CRC Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Prince of Wales Hospital

Randwick, New South Wales, Australia

Fiona Stanley Hospital

Perth, , Australia

Royal Perth Hospital

Perth, , Australia

Royal North Shore Hospital

Sydney, , Australia

Medical University Graz

Graz, Styria, Austria

Klinikum Hochsauerland

Arnsberg, , Germany

Auckland City Hospital

Auckland, , New Zealand

Countries

Australia; Austria; Germany; New Zealand

Other Identifiers

C1904

Identifier Type: -

Identifier Source: org_study_id