Clinical trial NCT02912715: BIOLUX P-IV CHINA ( BIOTRONIK )
Official title: Prospective, Multi-center, Non-randomized Clinical Trial of Passeo-18 Lux Drug Coated Balloon（DCB） in New and Non-stented Re-stenotic Lesions in the Superficial Femoral Artery (SFA) and Proximal Popliteal Artery (PPA) in a Chinese Patient Population
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Peripheral Arterial Disease
Lead sponsor: Biotronik (Beijing) Medical Device Ltd.
Sponsor class: INDUSTRY
First posted: 2016-09-23
Enrollment: 158
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: Prospective, multi-center, non-randomized clinical trial with follow-up investigations at 1, 6 and 12 months. To confirm safety and efficacy of Passeo-18 Lux DCB in new and non-stented re-stenotic lesions in the superficial femoral artery (SFA) and proximal popliteal artery (PPA) in a Chinese patient population.

Detailed description: A prospective, multi-centre, non-randomized clinical trial with follow-up investigations at 1, 6 and 12 months. Approximately 158 subjects will be enrolled at 15 Chinese study sites. To confirm the safety and efficacy of the Passeo-18 Lux DCB for the interventional treatment of new and non-stented re-stenotic lesions in the superficial femoral artery (SFA) and proximal popliteal artery (PPA) in a Chinese patient population.

Eligibility criteria: Inclusion Criteria:

* Age ≥ 18 years.
* Subject with documented diagnosis of peripheral arterial disease (PAD) classified as Rutherford class 2-3-4 in the superficial femoral artery (SFA) and/or proximal popliteal artery (PPA) above the knee, located in the arterial segment starting at least 1 cm beyond the common femoral artery (CFA) bifurcation between the superficial and profunda femoris arteries (proximal anatomical landmark) to the distal P1 segment of the popliteal artery at the level of the proximal edge of the patella (distal anatomical landmark).
* Subject able to walk without assistive devices (e.g. walker, cane).
* Female subjects of childbearing potential must have a negative pregnancy test ≤ 7 days before index procedure; Both male and female subjects are willing to use a reliable method of birth control for the duration of the study or must have documented adequate birth control.
* Signed and dated Patient Informed Consent (PIC) form.
* Subject understands and accepts the duration of the study and is able and willing to comply with all requirements, including follow-up visits and evaluations.
* Life expectancy, in the Investigator's opinion, of at least 12 months.
* Target lesion consists of a de novo or non-stented restenotic lesion with a ≥70% diameter stenosis.
* Lesion length≤ 200 mm.
* Reference vessel diameter ≥ 2 mm and ≤ 7 mm by visual estimate.
* Subject with ipsilateral/contralateral iliac disease that requires treatment during the index procedure can be included if treatment is successful (angiographic evidence of stenosis \<30%). Iliac disease should be treated firstly by marketed devices excluding drug eluted stent and drug coated balloon.
* Angiographic evidence of adequate distal run-off to the foot (at least one native calf vessel \[posterior tibial, anterior tibial, or peroneal arteries\] is patent, defined as \< 50% diameter stenosis).

Exclusion Criteria:

* Stroke or STEMI within 3 months prior to index procedure.
* Either local or systemic thrombolytic therapy within 48 hours prior to index procedure.
* Inability to tolerate oral anticoagulation therapy (blood thinners such as warfarin) while on concomitant dual antiplatelet therapy (DAPT).
* Known allergies or sensitivities to heparin, aspirin (ASA), other anticoagulant/anti-platelet therapies, and/or paclitaxel or an allergy to contrast media that cannot be adequately pre-treated prior to the index procedure.
* Breastfeeding women.
* Chronic renal insufficiency with serum creatinine \> 2.5 mg/dL within 14 days prior to index procedure.
* White blood cell count (WBC) \< 3,000 cells/mm3 within 14 days prior to index procedure.
* Platelet count \< 80,000 cells/mm3 or \> 700,000 cells/mm3 within 14 days prior to index procedure.
* Known or suspected active systemic infection evidenced by WBC \> 14.0 (14000/mm3) within 14 days prior to index procedure.
* Diagnosed with bleeding diatheses or hypercoagulable state.
* Subject is enrolled in any investigational device, drug or biologic study.
* Any major (e.g., cardiac. peripheral, abdominal) surgical procedure or planned intervention performed within 30 days prior to the index procedure.
* Any major (e.g., cardiac. peripheral, abdominal) elective procedure or intervention within 30 days post index procedure.
* Target lesion known in advance of enrollment to require treatment with alternative therapy such as (drug-eluting) stent, laser, atherectomy, cryoplasty, re-entry devices, cutting/scoring balloon, brachytherapy. Use of embolic protection devices is also prohibited.
* Contralateral SFA/PPA disease requiring treatment in the same setting as index procedure.
* Presence of additional lesions in the target vessel that require treatment during index procedure but do not meet the inclusion criteria.
* Complete occlusion lesion\> 100mm.
* Target lesion is an in-stent or post-DCB restenosis or has been previously treated with bypass surgery.
* Lesion within or adjacent to an aneurysm.
* Acute or sub-acute thrombus in the target vessel.
* Angiographic evidence of severe calcification.
* Failure to successfully cross the target lesion with a guide wire.
* Pre-dilation resulted in a major (≥ Grade D) flow-limiting dissection (observed on 2 orthogonal views) or residual stenosis \> 70% or translesional peak gradient \> 10mm Hg.

Primary outcomes:
measure: Major Adverse Events
timeFrame: 12 months
Secondary outcomes:
measure: Death of any cause
timeFrame: 30 days, 6 and 12 months
measure: Target lesion revascularization
timeFrame: 30 days, 6 and 12 months
measure: Clinically-driven target lesion revascularization
timeFrame: 30 days, 6 and 12 months
measure: Target vessel revascularization
timeFrame: 30 days, 6 and 12 months
measure: Clinically-driven target vessel revascularization
timeFrame: 30 days, 6 and 12 months
measure: Major target limb amputation
timeFrame: 30 days, 6 and 12 months
measure: Thrombosis at the target lesion site
timeFrame: 30 days, 6 and 12 months
measure: Primary sustained clinical improvement
timeFrame: 6 and 12 months
measure: Secondary sustained clinical improvement
timeFrame: 6 and 12 months
measure: Duplex-defined binary restenosis (PSVR > 2.4) of the target lesion
timeFrame: 6 and 12 months
measure: Walking capacity assessment by Walking Impairment Questionnaire
timeFrame: at baseline, 30 days, 6 and 12 months
measure: Walking distance as assessed by 6 Minute Walk Test
timeFrame: at baseline, 30 days, 6 and 12 months
measure: Quality of life assessment by EuroQol Five Dimensions（EQ5D） questionnaire
timeFrame: at baseline, 30 days, 6 and 12 months
measure: Device success
timeFrame: during the procedure
measure: Procedural success
timeFrame: during the procedure
measure: Clinical success
timeFrame: during the hospitalization
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Fudan University affiliated Zhongshan Hospital
state: Shanghai
Study officials:
affiliation: Fudan University
name: Weiguo Fu
role: PRINCIPAL_INVESTIGATOR
References:
citation: Fowkes FG, Rudan D, Rudan I, Aboyans V, Denenberg JO, McDermott MM, Norman PE, Sampson UK, Williams LJ, Mensah GA, Criqui MH. Comparison of global estimates of prevalence and risk factors for peripheral artery disease in 2000 and 2010: a systematic review and analysis. Lancet. 2013 Oct 19;382(9901):1329-40. doi: 10.1016/S0140-6736(13)61249-0. Epub 2013 Aug 1.