BRight DCB First-in-Human Study

NCT04525794 | Completed DMC

• 1 other identifier: C1904
• Study Type: interventional
• Target: 48
• Locations: 3 countries
• Sites: 3

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

Outcome Measures

Primary Outcomes (1)

• Late Lumen Loss

  Late Lumen Loss, as measure by quantitative vascular angiography (QVA)

  6 months post index procedure

Secondary Outcomes (14)

• Device success

  during procedure

• Acute technical success

  during procedure

• Acute procedural success

  72 hours post index procedure

• Major Adverse Event (MAE) rate

  1, 6 and 12 months post index procedure

• Clinically-driven Target Lesion Revascularization (cd TLR) rate

  1, 6 and 12 months post index procedure

Study Arms (1)

BRight DCB

EXPERIMENTAL

Device: BRight DCB

Interventions

BRight DCB 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.

BRight DCB

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)
• Rutherford-Becker Clinical Category of 2, 3 or 4
• Target vessel reference diameter ≥5 mm and ≤ 6 mm (by visual estimation)
• 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 ≤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.
• Successful guidewire crossing of lesion.
• After pre-dilatation, the target lesion is ≤ 30% residual stenosis with no flow limiting dissection and treatable with a single balloon
• Inflow artery is patent, free from significant lesion stenosis (\>50% stenosis considered significant) as confirmed by angiography.
• 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.)

You may not qualify if:

• 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
• Contraindication to dual anti-platelet therapy
• Subject is receiving chronic anticoagulation therapy (e.g. low molecular weight heparin, warfarin, or novel direct oral anticoagulants (N(D)OACs)).
• 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
• 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 prior to enrollment- contralateral iliac artery treatment with no drug eluting technology is allowed during the index procedure)
• 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)
• 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.

Sponsors & Collaborators

• Biotronik CRC Inc.: lead
• Biotronik AG: collaborator

Study Sites (7)

Prince of Wales Hospital

Randwick, New South Wales, 2031, Australia

Location

Fiona Stanley Hospital

Perth, Australia

Location

Royal Perth Hospital

Perth, Australia

Location

Royal North Shore Hospital

Sydney, Australia

Location

Medical University Graz

Graz, Styria, 8036, Austria

Location

Klinikum Hochsauerland

Arnsberg, 59759, Germany

Location

Auckland City Hospital

Auckland, New Zealand

Location

MeSH Terms

Conditions

Peripheral Arterial Disease

Condition Hierarchy (Ancestors)

Atherosclerosis; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases; Peripheral Vascular Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 13, 2020
• First Posted: August 25, 2020
• Study Start: February 4, 2021
• Primary Completion: September 20, 2023
• Study Completion: February 2, 2024
• Last Updated: May 22, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

AU (1); DE (1); NZ (1)