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)

Biotronik CRC Inc.7 sites in 4 countries48 target enrollmentFebruary 4, 2021

ConditionsPeripheral Artery Disease

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Peripheral Artery Disease
Sponsor: Biotronik CRC Inc.
Enrollment: 48
Locations: 7
Primary Endpoint: Late Lumen Loss
Status: Completed
Last Updated: last year

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

February 4, 2021

End Date

February 2, 2024

Last Updated

last year

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Biotronik CRC Inc.

Responsible Party

Sponsor

Eligibility Criteria

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

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)

Outcomes

Primary Outcomes

Late Lumen Loss

Time Frame: 6 months post index procedure

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

Secondary Outcomes

Device success(during procedure)
Acute technical success(during procedure)
Clinically-driven Target Lesion Revascularization (cd TLR) rate(1, 6 and 12 months post index procedure)
Clinically-driven Target Vessel Revascularization (cd TVR) rate(1, 6 and 12 months post index procedure)
Target lesion primary patency(1, 6 and 12 months post index procedure)
Change in resting target limb Ankle Brachial Index (ABI) as compared to baseline(1, 6 and 12 months post index procedure)
Major Adverse Event (MAE) rate(1, 6 and 12 months post index procedure)
All-cause of death rate(1, 6 and 12 months post index procedure)
Target lesion Binary Restenosis(1, 6 and 12 months post index procedure)
Acute procedural success(72 hours post index procedure)
Amputation (minor and major) rate(1, 6 and 12 months post index procedure)
Change in the Walking Impairment questionnaire (WIQ) as compared to baseline(1, 6 and 12 months post index procedure)
Embolic event of the index limb(during procedure)
Change in Rutherford Classification as compared to baseline(1, 6 and 12 months post index procedure)