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Clinical Study of Passeo-18 Lux Balloon Catheter for the Treatment of Atherosclerotic Lesions(BIOLUX-P IV CHINA)

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ClinicalTrials.gov Identifier: NCT02912715
Recruitment Status : Unknown
Verified September 2016 by Biotronik (Beijing) Medical Device Ltd..
Recruitment status was:  Not yet recruiting
First Posted : September 23, 2016
Last Update Posted : September 23, 2016
Sponsor:
Information provided by (Responsible Party):
Biotronik (Beijing) Medical Device Ltd.

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.

Condition or disease Intervention/treatment Phase
Peripheral Arterial Disease Device: Paclitaxel releasing angioplasty balloon Phase 3

Detailed Description:
A prospective, multi-centre, non-randomized clinical trial with follow-up investigations at 1, 6 and 12 months. Approximately 250 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.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 158 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Prospective, Multi-center, Non-randomized Clinical Trial 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
Study Start Date : November 2016
Estimated Primary Completion Date : September 2018
Estimated Study Completion Date : September 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Angioplasty
Drug Information available for: Paclitaxel

Arm Intervention/treatment
Experimental: Paclitaxel releasing angioplasty balloon
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
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.




Primary Outcome Measures :
  1. Major Adverse Events [ Time Frame: within 30 days post-index procedure ]
    a composite of device- and procedure-related mortality, major target limb amputation and clinically-driven TLR within 30-day post-index procedure.


Secondary Outcome Measures :
  1. Death of any cause [ Time Frame: 30 days, 6 and 12 months ]
  2. target lesion revascularization [ Time Frame: 30 days, 6 and 12 months ]
  3. Clinically-driven target lesion revascularization [ Time Frame: 30 days, 6 and 12 months ]
  4. target vessel revascularization [ Time Frame: 30 days, 6 and 12 months ]
  5. Clinically-driven target vessel revascularization [ Time Frame: 30 days, 6 and 12 months ]
  6. Major target limb amputation [ Time Frame: 30 days, 6 and 12 months ]
  7. Thrombosis at the target lesion site [ Time Frame: 30 days, 6 and 12 months ]
  8. Primary sustained clinical improvement [ Time Frame: 6 and 12 months ]
  9. Secondary sustained clinical improvement [ Time Frame: 6 and 12 months ]
  10. Duplex-defined binary restenosis (PSVR > 2.4) of the target lesion [ Time Frame: 6 and 12 months ]
  11. Walking capacity assessment by Walking Impairment Questionnaire [ Time Frame: at baseline, 30 days, 6 and 12 months ]
  12. Walking distance as assessed by 6 Minute Walk Test [ Time Frame: at baseline, 30 days, 6 and 12 months ]
  13. Quality of life assessment by EQ5D questionnaire [ Time Frame: at baseline, 30 days, 6 and 12 months ]
  14. Successful delivery, balloon inflation, deflation and retrieval of the intact study device without burst below the rated burst pressure [ Time Frame: during the procedure ]
  15. Residual stenosis of ≤ 50% (non-stented subjects) or ≤ 30% (stented subjects) by core lab assessment [ Time Frame: during the procedure ]
  16. Procedural success without procedural complications [ Time Frame: during the hospitalization ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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. Successful crossing refers to the tip of the device extending beyond the target lesion, with no occurrence of flow-limiting dissections and/or perforations.
  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02912715


Contacts
Contact: Weiguo Fu +86 02164041990 fu.weiguo@zs-hospital.sh.cn

Locations
China, Shanghai
Fudan University affiliated Zhongshan Hospital Not yet recruiting
Shanghai, Shanghai, China, 200032
Contact: Weiguo Fu    +86 02164041990    fu.weiguo@zs-hospital.sh.cn   
Sponsors and Collaborators
Biotronik (Beijing) Medical Device Ltd.
Investigators
Principal Investigator: Weiguo Fu Fudan University

Additional Information:
Publications of Results:
Responsible Party: Biotronik (Beijing) Medical Device Ltd.
ClinicalTrials.gov Identifier: NCT02912715     History of Changes
Other Study ID Numbers: C1303
First Posted: September 23, 2016    Key Record Dates
Last Update Posted: September 23, 2016
Last Verified: September 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes

Additional relevant MeSH terms:
Peripheral Arterial Disease
Peripheral Vascular Diseases
Atherosclerosis
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases
Paclitaxel
Albumin-Bound Paclitaxel
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action