Clinical trial NCT02965677: A Study of The Femoral Popliteal Artery Treated With LEGFLOW OTW
Official title: Evaluation of the Safety and Efficacy of the Paclitaxel Releasing Peripheral Balloon Dilatation Catheter （LEGFLOW）in Treatment of Stenosis or Occlusion in Femoral-popliteal Arteries：A Prospective, Multicenter, Randomized, Controlled Clinical Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Peripheral Arterial Disease
Keywords: drug eluting balloon
Femoral Popliteal Artery
Lead sponsor: ZhuHai Cardionovum Medical Device Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2016-11-17
Enrollment: 172
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To evaluate the safety and efficacy of the Paclitaxel Releasing Peripheral Balloon Dilatation Catheter (LEGFLOW) compared with the standard balloon (Admiral Xtreme) for the treatment of stenosis or occlusions in femoral popliteal artery.

Detailed description: To evaluate the safety and efficacy of the Paclitaxel Releasing Peripheral Balloon Dilatation Catheter (LEGFLOW) compared with the standard balloon (Admiral Xtreme) for the treatment of stenosis or occlusions in femoral popliteal artery.

This is a prospective, multicenter, prior desiged, randomize and controlled study, planned to enrol 172 subjects. all these subjects will be allocated 1:1 to the LEGFLOW OTW group n=86 and Admiral Xtreme group n=86. and accept the treatment of LEGFLOW and Admiral Xtreme balloon. and followed up at day 0-30, month 6, 12 by DUS and clinical examination. all the endpoint data will be assessed by DUS core-lab, CEC, then be statisticed.

Eligibility criteria: Inclusion Criteria:

1. Age ≥ 18 years and ≤ 85 years.
2. De novo or restenotic lesions in the femoral popliteal artery due to atherosclerosis, which located in the superficial femoral artery and/or proximal popliteal artery (arterial segment starting at least 1cm beyond the common femoral artery bifurcation to the distal P1 segment of the popliteal artery at the level of the proximal edge of the patella). And the patients are suitable for endovascular therapy with LEGFLOW OTW or Admiral Xtreme.
3. Rutherford class 2 to 5.
4. Target lesion length ≤ 200mm.
5. Target lesion stenosis ≥ 70% or total occlusion, and it can be passed with common manipulation.
6. Reference vessel diameter ≥ 4mm and ≤ 8mm by visual estimate.
7. Target lesion consists of a single of de novo or restenotic lesion, or a adjacent lesion or a combination lesion or multiple lesion which meets the following criteria:

   * adjacent lesion: (1) lesion space ≤ 30mm; (2) total lesion length (include lesion space) ≤ 200mm; (3) can be treated as a single lesion.
   * Combination lesion: combination lesion is defined as not a chronic total occlusion (CTO), but may include a part of total occlusion (100% stenosis). The total lesion length ≤ 200mm.
   * Multiple lesion: (1) lesion space \> 30mm; (2) total lesion length (include lesion space) ≤ 200mm; (3) can be treated as multiple lesions.
8. Angiographic evidence of adequate distal run-off to the foot (at least one native calf vessel is patent, defined as \< 50% diameter stenosis), whether or not this outfolw was re-established by previous intervention.
9. If subject has ipsilateral/contralateral iliac disease that requires treatment during the procedure, the iliac lesions must meet all the following criteria:

   * Iliac lesion or occlusion is ≤ 100mm in length;
   * must be treated before the target lesion (superficial femoral artery/proximal popliteal artery).
   * must be successfully treated before target lesion treatment; success is defined as: (1) residual stenosis \< 30%; (2) free of dissection which can limit blood flow; (3) no occurrence of thrombus, embolization, or other SAE.
10. Life expectancy more than one year.
11. Understands the study objective and is willing to participate and provide the informed consent form, and is willing to comply with specified follow-up evaluations at the specified time points.

Exclusion Criteria:

1. Women of childbearing age with negative pregnancy test before procedure, and breastfeeding women.
2. Stroke or STEMI within 30 days prior to the procedure.
3. Either local or systemic thrombolytic therapy within 6 weeks prior to the procedure.
4. Any major surgical operation (operation class ≥ 3) or interventional therapy within 30 days prior to the procedure.
5. Any major selective surgical operation (operation class ≥ 3) or interventional therapy within 30 days prior to the procedure.
6. Restenotic lesions after DCB or bypass surgery.
7. Target limb has been previously treated with bypass surgery.
8. Guidewire must be passed through from the distal part of limb.
9. Known allergies or sensitivities to contrast agent, paclitaxel, anti-platelet, anticoagulants or thrombolytic drugs.
10. Known allergies or sensitivities to heparin, including those patients who have had a previous incidence of heparin-induced thrombocytopenia (HIT) type II.
11. Aneurysm located at the target vessel.
12. Acute or sub-acute thrombosis in the target vessel.
13. Angiographic evidence of severe calcification (defined as dense circumferential calcification that makes the target lesion non-dilatable and/or calcificatin that is present on both sides of the vessel wall and that extends more than 5 cntinuous centimeters in length within the target lesion prior to contrast injection or digital subtraction angiography).
14. The bilateral lower limb must be treated in one procedure.
15. Uncorrected bleeding disorder.
16. Renal insufficiency (serum creatinine \>2.5mg/dL or renal dialysis).
17. Stenosis or occlusions due to non-atherosclerosis, such as thrombotic occlusive vasculitis or vasculitis.
18. Septicemia or bacteremia.
19. Patients with severe disease (such as severe chronic obstructive pulmonary disease, malignant tumor, dementia, etc.) or patient's physical condition may affect the compliance with this study.
20. Pre-dilation resulted in a major (≥ Grade D) flow-limiting dissection or residual stenosis \> 70%.
21. Major distal amputation (above the transmetatarsal) in the study limb or non-study limb.
22. Patients who have participated in another investigational drug or device trial that has not completed the primary endpoint.

Primary outcomes:
measure: clinically driven target lesion revascularization (CD-TLR)
timeFrame: 12 month post procedure
Secondary outcomes:
measure: Procedural Success
timeFrame: at 0-30 days
measure: Device Success
timeFrame: at 0-30 days
measure: Clinical Success
timeFrame: at 0-30 days
measure: Change in Rutherford classification measured
timeFrame: at 0-30 days, 6 months and 12 months post procedure
measure: Change in ABI measure
timeFrame: at 0-30 days, 6 months and 12 months post procedure
measure: Walking capacity assessment by Walking Impairment Questionnaire (WIQ)
timeFrame: at 0-30 days, 6 months and 12 months post procedure
measure: Walking distance assessment by Six Minute Walk Test (6MWT)
timeFrame: 0-30 days, 6 months and 12 months post procedure compared with baseline
measure: Quality of life assessment by EQ5D
timeFrame: at 0-30 days, 6 months and 12 months post procedure compared with baseline
measure: Target lesion revascularization (TLR)
timeFrame: 0-30 days, 6 months and 12 months post procedure
measure: Target vessel revascularization (TVR)
timeFrame: at 0-30 days, 6 months and 12 months post procedure
measure: Thrombus at the target lesion site
timeFrame: 0-30 days, 6 months and 12 months post procedure
measure: Target limb amputation rates
timeFrame: at 0-30 days, 6 months and 12 months post procedure
measure: Major Adverse Event (MAE) rate which including all cause death, CD-TLR and major target limb amputation.
timeFrame: at 0-30 days, 6 months and 12 months post procedure
measure: Clinical-driven target vessel revascularization (CD-TVR) rates
timeFrame: at 0-30 days, 6 months and 12 months post procedure
measure: Clinical-driven target lesion revascularization (CD-TLR) rates
timeFrame: at 0-30 days, 6 months and 12 months post procedure
Other outcomes:
Locations:
city: Fuzhou
country: China
facility: The First Affiliated Hospital of Fujian Medical University
state: Fujian
city: Haikou
country: China
facility: Hainan General Hospital
state: Hainan
city: Shijiazhuang
country: China
facility: The First hospital of Hebei Medical University
state: Hebei
city: Changsha
country: China
facility: Xiangya Hospital Central South University
state: Hunan
city: Xi'an
country: China
facility: The First Affiliated Hospital of Xi'an Jiaotong University
state: Shanxi
city: Beijing
country: China
facility: Beijing Anzhen Hospital, Capital Medical University
city: Beijing
country: China
facility: Beijing Chao-yang Hospital, Capital Medical University
city: Beijing
country: China
facility: Beijing Hospital
city: Beijing
country: China
facility: Beijing Shijitan Hospital, Capital Medical University
city: Beijing
country: China
facility: Fuwai Hospital, Chinese Accadamy of Medical Sciences
city: Shanghai
country: China
facility: Longhua Hospital Shanghai University of Tranditional Chinese Medicine
city: Shanghai
country: China
facility: Shanghai Ninth people's Hospital, Shanghai Jiaotong University School of Medicine
city: Tianjin
country: China
facility: Tianjin Medical University General Hospital
Study officials:
affiliation: Chinese PLA Genral Hospital
name: Guo Wei, professor
role: PRINCIPAL_INVESTIGATOR
References: