- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04525794
BRight DCB First-in-Human Study
August 8, 2023 updated by: Biotronik CRC Inc.
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)
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.
Study Overview
Status
Active, not recruiting
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
48
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: HELENE KUISSU
- Phone Number: +41 44 864 53 68
- Email: helene.kuissu@biotronik.com
Study Locations
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Perth, Australia
- Royal Perth Hospital
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Perth, Australia
- Fiona Stanley Hospital
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Sydney, Australia
- Royal North Shore Hospital
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New South Wales
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Randwick, New South Wales, Australia, 2031
- Prince of Wales Hospital
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Styria
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Graz, Styria, Austria, 8036
- Medical University Graz
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Arnsberg, Germany, 59759
- Klinikum Hochsauerland
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Auckland, New Zealand
- Auckland City Hospital
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- 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.)
Exclusion Criteria:
- 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.
- Subject has known or suspected active infection at the time of the index procedure.
- Subject has platelet count < 100,000/mm3 or > 700,000/mm3.
- Subject has white blood cell (WBC) count < 3,000/mm3.
- Subject is unable to tolerate blood transfusions because of religious beliefs or other reasons.
- Subject has history of gastrointestinal hemorrhage requiring a transfusion within 3 months prior to the index procedure.
- 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
- 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)
- Non femoral vascular access
- Target lesion would require treatment with more than one balloon
- Known inadequate distal outflow
- Acute or sub-acute thrombus in the target vessel
- Aneurysmal target vessel
- Use of adjunctive therapies (i.e. laser, atherectomy, cryoplasty, scoring/cutting balloon, brachytherapy) during the study procedure in the target lesion or target vessel
- Presence of concentric calcification that precludes PTA pre-dilatation
- Significant contralateral or ipsilateral common femoral disease that requires intervention during the index procedure
- Persistent hemodynamically-significant stenosis following predilatation or residual stenosis of >30%, stent placement, or flow-limiting (Grade D or greater) dissection following pre-dilatation
- In-stent restenosis
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Experimental: BRight DCB
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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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Late Lumen Loss
Time Frame: 6 months post index procedure
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Late Lumen Loss, as measure by quantitative vascular angiography (QVA)
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6 months post index procedure
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
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Device success
Time Frame: during procedure
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Successful delivery, balloon inflation/deflation and retrieval of the intact trial device
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during procedure
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Acute technical success
Time Frame: during procedure
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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
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during procedure
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Acute procedural success
Time Frame: 72 hours post index procedure
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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
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72 hours post index procedure
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Major Adverse Event (MAE) rate
Time Frame: 1, 6 and 12 months post index procedure
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MAE is a composite of device or procedure related death within 30 days post index procedure, major index limb amputation, cd TLR
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1, 6 and 12 months post index procedure
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Clinically-driven Target Lesion Revascularization (cd TLR) rate
Time Frame: 1, 6 and 12 months post index procedure
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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.
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1, 6 and 12 months post index procedure
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Clinically-driven Target Vessel Revascularization (cd TVR) rate
Time Frame: 1, 6 and 12 months post index procedure
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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.
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1, 6 and 12 months post index procedure
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All-cause of death rate
Time Frame: 1, 6 and 12 months post index procedure
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1, 6 and 12 months post index procedure
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Amputation (minor and major) rate
Time Frame: 1, 6 and 12 months post index procedure
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rate of amputation (minor and major)
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1, 6 and 12 months post index procedure
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Change in Rutherford Classification as compared to baseline
Time Frame: 1, 6 and 12 months post index procedure
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change in the Rutherford classification between baseline and follow-up
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1, 6 and 12 months post index procedure
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Change in resting target limb Ankle Brachial Index (ABI) as compared to baseline
Time Frame: 1, 6 and 12 months post index procedure
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change in ABI between baseline and follow-up
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1, 6 and 12 months post index procedure
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Target lesion Binary Restenosis
Time Frame: 1, 6 and 12 months post index procedure
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Defined as duplex ultrasound peak systolic velocity ratio (PSVR) > 2.5 (if DUS is completed) or angiographic assessment which suggests stenosis > 50% by QVA
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1, 6 and 12 months post index procedure
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Target lesion primary patency
Time Frame: 1, 6 and 12 months post index procedure
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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)
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1, 6 and 12 months post index procedure
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Change in the Walking Impairment questionnaire (WIQ) as compared to baseline
Time Frame: 1, 6 and 12 months post index procedure
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change in WIQ between baseline and follow-up
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1, 6 and 12 months post index procedure
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Embolic event of the index limb
Time Frame: during procedure
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occurrence of embolic event as visualized on angiography
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during procedure
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
February 4, 2021
Primary Completion (Estimated)
September 1, 2023
Study Completion (Estimated)
April 1, 2024
Study Registration Dates
First Submitted
August 13, 2020
First Submitted That Met QC Criteria
August 24, 2020
First Posted (Actual)
August 25, 2020
Study Record Updates
Last Update Posted (Actual)
August 9, 2023
Last Update Submitted That Met QC Criteria
August 8, 2023
Last Verified
August 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- C1904
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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