Clinical trial NCT04525794: BRight DCB First-in-Human Study
Official 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)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Peripheral Artery Disease
Lead sponsor: Biotronik CRC Inc.
Sponsor class: INDUSTRY
Collaborators: name: Biotronik AG
First posted: 2020-08-25
Enrollment: 48
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Late Lumen Loss
timeFrame: 6 months post index procedure
Secondary outcomes:
measure: Device success
timeFrame: during procedure
measure: Acute technical success
timeFrame: during procedure
measure: Acute procedural success
timeFrame: 72 hours post index procedure
measure: Major Adverse Event (MAE) rate
timeFrame: 1, 6 and 12 months post index procedure
measure: Clinically-driven Target Lesion Revascularization (cd TLR) rate
timeFrame: 1, 6 and 12 months post index procedure
measure: Clinically-driven Target Vessel Revascularization (cd TVR) rate
timeFrame: 1, 6 and 12 months post index procedure
measure: All-cause of death rate
timeFrame: 1, 6 and 12 months post index procedure
measure: Amputation (minor and major) rate
timeFrame: 1, 6 and 12 months post index procedure
measure: Change in Rutherford Classification as compared to baseline
timeFrame: 1, 6 and 12 months post index procedure
measure: Change in resting target limb Ankle Brachial Index (ABI) as compared to baseline
timeFrame: 1, 6 and 12 months post index procedure
measure: Target lesion Binary Restenosis
timeFrame: 1, 6 and 12 months post index procedure
measure: Target lesion primary patency
timeFrame: 1, 6 and 12 months post index procedure
measure: Change in the Walking Impairment questionnaire (WIQ) as compared to baseline
timeFrame: 1, 6 and 12 months post index procedure
measure: Embolic event of the index limb
timeFrame: during procedure
Other outcomes:
Locations:
city: Randwick
country: Australia
facility: Prince of Wales Hospital
state: New South Wales
city: Perth
country: Australia
facility: Fiona Stanley Hospital
city: Perth
country: Australia
facility: Royal Perth Hospital
city: Sydney
country: Australia
facility: Royal North Shore Hospital
city: Graz
country: Austria
facility: Medical University Graz
state: Styria
city: Arnsberg
country: Germany
facility: Klinikum Hochsauerland
city: Auckland
country: New Zealand
facility: Auckland City Hospital
Study officials:
References: