Peripheral Arterial DiseaseNCT02912715
BIOLUX P-IV CHINA ( BIOTRONIK )
A study testing Paclitaxel releasing angioplasty balloon in people with Peripheral Arterial Disease, run by Biotronik (Beijing) Medical Device Ltd. at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Peripheral Arterial Disease
- What is being tested?
- Paclitaxel releasing angioplasty balloon
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 158 participants
- Where
- 1 siteChina
- Study dates
- Oct 2016to Aug 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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).
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
China1 site
Fudan University affiliated Zhongshan Hospital
Shanghai, Shanghai Municipality, 200032
About this study
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
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.
Read the 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.
- Conditions
- Peripheral Arterial Disease
- Being tested
- Paclitaxel releasing angioplasty balloon
- Medical subject headings
- Peripheral Arterial Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Paclitaxel releasing angioplasty balloonDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| 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) Receives: Device: Paclitaxel releasing angioplasty balloon |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 12 months
Secondary outcomes (16)
Death of any cause
the all-cause mortality of subjects at 30 days, 6 months and 12 months after index procedure
Measured: 30 days, 6 and 12 months
Target lesion revascularization
TLR,Target lesion revascularization.In the subjects experiencing target lesion revascularization, the two revascularizations were both judged as clinically driven target lesion revascularization.
Measured: 30 days, 6 and 12 months
Clinically-driven target lesion revascularization
Defined as any re-intervention at the target lesion due to symptoms or drop of ABI/TBI of≥20% or >0.15 when compared to post-procedure baseline ABI/TBI（Ankle Brachial Index/Toe Brachial Index）. Clinically driven TLR will be adjudicated by an independent Clinical Event Committee
Measured: 30 days, 6 and 12 months
Target vessel revascularization
TVR,Target vessel revascularization.The target vessel revascularization of subjects at 30 days, 6 months, and 12 months after index procedure.Defined as any re-intervention at the target vessel due to symptoms or drop of ABI/TBI of≥20% or >0.15 when compared to post-procedure baseline ABI/TBI. Clinically driven TVR will be adjudicated by an independent Clinical Event Committee
Measured: 30 days, 6 and 12 months
Clinically-driven target vessel revascularization
Defined as any re-intervention at the target vessel due to symptoms or drop of ABI/TBI of≥20% or >0.15 when compared to post-procedure baseline ABI/TBI. Clinically driven TVR will be adjudicated by an independent Clinical Event Committee
Measured: 30 days, 6 and 12 months
Major target limb amputation
Surgical removal of tissue within the affected limb.
- Above-knee amputation: amputation at a point above the knee
- Below-knee amputation: amputation at a point below the knee
Measured: 30 days, 6 and 12 months
Thrombosis at the target lesion site
Rapidly developing into total occlusion due to thrombosis confirmed by sudden onset of symptoms and recorded by Doppler ultrasound and/or angiography. Thrombosis can be classified as acute (<1 day), subacute (1-30 days) and late (> 30 days).
Measured: 30 days, 6 and 12 months
Primary sustained clinical improvement
Primary sustained clinical improvement at 6 months and 12 months after index procedure is defined as sustained upward shift of at least 1 category on Rutherford classification as compared to baseline without further endovascular or surgical revascularization procedure(s) at target lesion.
Measured: 6 and 12 months
Secondary sustained clinical improvement
Secondary sustained clinical improvement at 6 months and 12 months after surgery defined as sustained upward shift of at least 1 category on Rutherford classification as compared to baseline including further endovascular or surgical revascularization procedures at target lesion.
Measured: 6 and 12 months
Duplex-defined binary restenosis (PSVR > 2.4) of the target lesion
Binary restenosis of the target lesion determined by Duplex ultrasound at the time of re-intervention before 6 months and 12 months after index procedure or any prescheduled time point was judged by PSVR > 2.4.
Measured: 6 and 12 months
Walking capacity assessment by Walking Impairment Questionnaire
Changes in walking ability assessed with the Walking Impairment Questionnaire (WIQ) at baseline, 30 days, 6 months, and 12 months after index procedure.
Measured: at baseline, 30 days, 6 and 12 months
Walking distance as assessed by 6 Minute Walk Test
Changes in the walking distance assessed with the 6-minute walking test (6MWT) at baseline, 30 days, 6 months, and 12 months after index procedure.
Measured: at baseline, 30 days, 6 and 12 months
Quality of life assessment by EuroQol Five Dimensions（EQ5D） questionnaire
Changes in quality of life assessed with the EQ5D questionnaire at baseline, 30 days, 6 months, and 12 months after index procedure.
Measured: at baseline, 30 days, 6 and 12 months
Device success
Device success referred to the intact investigational device successfully performing delivery, balloon inflation, deflation, and withdrawal without bursting below the rated burst pressure (RBP).
Measured: during the procedure
Procedural success
Procedural success referred to residual stenosis ≤ 50% (for subjects without stent) or ≤ 30% (for subjects with stent) as accessed by the core laboratory.
Measured: during the procedure
Clinical success
Clinical success, defined as procedural success without procedural complications (death, major target limb amputation, thrombosis of the target lesion, or TVR) prior to discharge.
Measured: during the hospitalization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Sep 2016 (estimated)
- Study startOct 2016
- Primary completionAug 2020
- Study completionAug 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Peripheral Arterial DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 158 participants (actual)
Sponsor and investigators
- Lead sponsor
- Biotronik (Beijing) Medical Device Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Weiguo Fu, Principal investigator, Fudan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02912715
- Sponsor's protocol ID
- C1303
- Status last verified
- Sep 2022
- First submitted
- 8 Sep 2016
- Last updated
- 21 Aug 2023
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
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.
PubMed 23915883Yang 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.
PubMed 36796585
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02912715
- Acronym / sponsor ID
- C1303
- Conditions
- Peripheral Arterial Disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 158 participants (actual)
- Lead sponsor
- Biotronik (Beijing) Medical Device Ltd.Industry (pharma, biotech, devices)
- Study start
- Oct 2016 (actual)
- Primary completion
- Aug 2020 (actual)
- Study completion
- Aug 2020 (actual)
- First posted
- 23 Sep 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Paclitaxel releasing angioplasty balloon | Experimental | Device: Paclitaxel releasing angioplasty balloonIntervention 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) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- 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.
Key exclusion criteria (23 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Paclitaxel releasing angioplasty balloonPaclitaxel 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. | Device | Paclitaxel releasing angioplasty balloon |
Primary outcome
Major Adverse Events
Time frame: 12 months
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.
16 secondary outcomes
Death of any cause
Time frame: 30 days, 6 and 12 months
Target lesion revascularization
Time frame: 30 days, 6 and 12 months
Clinically-driven target lesion revascularization
Time frame: 30 days, 6 and 12 months
Target vessel revascularization
Time frame: 30 days, 6 and 12 months
Clinically-driven target vessel revascularization
Time frame: 30 days, 6 and 12 months
Major target limb amputation
Time frame: 30 days, 6 and 12 months
Thrombosis at the target lesion site
Time frame: 30 days, 6 and 12 months
Primary sustained clinical improvement
Time frame: 6 and 12 months
Secondary sustained clinical improvement
Time frame: 6 and 12 months
Duplex-defined binary restenosis (PSVR > 2.4) of the target lesion
Time frame: 6 and 12 months
Walking capacity assessment by Walking Impairment Questionnaire
Time frame: at baseline, 30 days, 6 and 12 months
Walking distance as assessed by 6 Minute Walk Test
Time frame: at baseline, 30 days, 6 and 12 months
Quality of life assessment by EuroQol Five Dimensions（EQ5D） questionnaire
Time frame: at baseline, 30 days, 6 and 12 months
Device success
Time frame: during the procedure
Procedural success
Time frame: during the procedure
Clinical success
Time frame: during the hospitalization
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Aug 2023.
- Results publication: PubMed 23915883Fowkes 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.
- Derived from this study: PubMed 36796585Yang 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.
- test linkLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Peripheral Arterial Disease
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Weiguo Fu principal investigator
Fudan University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Paclitaxel releasing angioplasty balloon in people with Peripheral Arterial Disease, run by Biotronik (Beijing) Medical Device Ltd. at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 23 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Major Adverse Events (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02912715, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Aug 2023.