BIOLUX P-IV CHINA ( BIOTRONIK )

NCT02912715 | Completed

• 1 other identifier: C1303
• Study Type: interventional
• Target: 158
• Locations: 1 country
• Sites: 1

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.

Conditions

Peripheral Arterial Disease

Outcome Measures

Primary Outcomes (1)

• Major Adverse Events

  a composite of device- and procedure-related mortality, major target limb amputation and clinically-driven target lesion revascularization（TLR） within 12-months post-initial procedure.

  12 months

Secondary Outcomes (16)

• Death of any cause

  30 days, 6 and 12 months

• Target lesion revascularization

  30 days, 6 and 12 months

• Clinically-driven target lesion revascularization

  30 days, 6 and 12 months

• Target vessel revascularization

  30 days, 6 and 12 months

• Clinically-driven target vessel revascularization

  30 days, 6 and 12 months

Study Arms (1)

Paclitaxel releasing angioplasty balloon

EXPERIMENTAL

Intervention treatment of balloon angioplasty with Paclitaxel releasing angioplasty balloon(Passeo-18 Lux) in new and non-stented re-stenotic lesions in the superficial femoral artery (SFA) and proximal popliteal artery (PPA)

Device: Paclitaxel releasing angioplasty balloon

Interventions

Paclitaxel releasing angioplasty balloon DEVICE

Paclitaxel releasing angioplasty balloon catheter is advanced through an introducer sheath and tracked over the wire until reaching the target lesion. The balloon can be precisely positioned by means of the radiopaque markers crimped on the inner shaft of the catheter. The catheter is dilated up to its intended diameter by inflating the balloon with a solution containing contrast media, causing a compression of the arterial plaque against the inner lining of the arterial wall and improving blood flow. After balloon inflation, the drug-carrier adheres to the arterial wall and facilitates the drug release to surrounding tissue. As there is no need for sustained release of Paclitaxel after the inflation, the drug carrier dissolves rapidly.

Paclitaxel releasing angioplasty balloon

Eligibility Criteria

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

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Biotronik (Beijing) Medical Device Ltd.: lead

Study Sites (1)

Fudan University affiliated Zhongshan Hospital

Shanghai, Shanghai Municipality, 200032, China

Location

Related Publications (2)

• 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.

  PMID: 23915883 RESULT

• Yang J, Yue J, Chen X, Wang H, Jiang W, Huang X, Lu X, Dong H, Li X, Fu W. Safety and Efficacy of the Passeo-18 Lux Drug-Coated Balloon Catheter in Atherosclerotic Femoropopliteal Lesions: The Multicenter BIOLUX P-IV China Study. Ann Vasc Surg. 2023 Jul;93:275-282. doi: 10.1016/j.avsg.2023.01.040. Epub 2023 Feb 14.

  PMID: 36796585 DERIVED

Related Links

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MeSH Terms

Conditions

Peripheral Arterial Disease

Condition Hierarchy (Ancestors)

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

Study Officials

• Weiguo Fu

  Fudan University

  PRINCIPAL INVESTIGATOR

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: September 8, 2016
• First Posted: September 23, 2016
• Study Start: October 1, 2016
• Primary Completion: August 1, 2020
• Study Completion: August 1, 2020
• Last Updated: August 21, 2023

Record last verified: 2022-09

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)