A Trial to Evaluate the Safety and Efficacy of the Passeo-18 Lux Drug-coated Balloon of Biotronik in the Treatment of the Femoropopliteal Artery Compared to the Medtronic IN.PACT Admiral Drug-coated Balloon. (BIOPACT-RCT)
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|ClinicalTrials.gov Identifier: NCT03884257|
Recruitment Status : Not yet recruiting
First Posted : March 21, 2019
Last Update Posted : March 21, 2019
The BIOPACT RCT tiral investigates the efficacy and safety of stenosis, restenosis or occlusions in the femoropopliteal artery of patients presenting a rutherford classification 2,3 or 4 with a Passeo-18 Lux drug-coated balloon of Biotronik. The Paclitaxel eluting balloons are designed for percutaneous transluminal angioplasties in which the balloon will dilate the artery upon inflation and deliver the paclitaxel locally.
An expected total of 151 patients will be treated with the Passeo-18 Lux and compared to a control group of another 151 patients that will be treated with the IN.PACT Admiral drug-coated balloon of Medtronic. Assignment to the treatment groups will be at random. The study will be conducted in two phases. A first pilot study phase of 120 patients distributed evenly over both treatment groups and a second phase to formally test the non-inferiority hypothesis.
The balloon is coated with Paclitaxel intended to avoid cellular proliferation. The drug is released by means of rapid inflation as to release a high dose in a short amount of time. Patients will be invited for a follow-up visit at 1, 6 and 12 months post-procedure.
The primary efficacy endpoints are defined as follows. Freedom from clinically-driven target lesion revascularization at 12 months. Freedom from device- and procedure-related death through 30 days post-index procedure, major target limb amputation through 12 months post-procedure and clinically-driven target vessel revascularization through 12 months post-index procedure. The secondary endpoints are defined as acute device success, acute procedural success , freedom from all cause of death, major target limb amputation and clinically driven target vessel revascularisation through 30 days post-procedure, sustained clinical improvement, no major adverse events through 6 and 12 months post-procedure, primary patency, target lesion revascularisation, target vessel revascularisation, binary restenosis, major target limb amputation, thrombosis at target lesion, change of walking impairment questionnaire score from baseline, change in target limb rutherford classification or ABI.
|Condition or disease||Intervention/treatment||Phase|
|Peripheral Arterial Disease||Device: Passeo-18 Lux treatment group Device: IN.PACT Admiral treatment group||Not Applicable|
The objective of this clinical investigation is to assess the safety and efficacy of the Passeo-18 Lux DCB for the treatment of stenotic, restenotic or occlusive lesions of the femoropopliteal arteries. Furthermore a non-inferiority hypothesis will be tested with the IN.PACT Admiral DCB as comparator.
The patients will be selected based on the investigator's assessment, evaluation of the underlying disease and the eligibility criteria. The patient's medical condition should be stable, with no underlying medical condition which would prevent them from performing the required testing or from completing the study. Patients should be geographically stable, willing and able to cooperate in this clinical study, and remain available for long term follow-up. The patient is considered enrolled in the study after obtaining the patients informed consent, if there is full compliance with the study eligibility criteria and after successful guidewire passage through the study target lesion.
Prior to the index procedure the following will be collected: an informed consent for data collection, demographics, medical history, medication record, physical examination, clinical category of acute limb ischemia (Rutherford category), the resting ankle-brachial index (ABI), blood sample test (complete blood count, comprehensive metabolic panel and if applicable pregnancy test) and a walking impairment questionnaire.
During the procedure the guidewire will cross the entire study lesion after which the lesion will be assessed through angiography. A pre-dilatation with a standard non-drug-coated balloon will be performed followed by a dilatation of the lesion with either a Passeo-18 Lux (Biotronik) or an IN.PACT Admiral balloon (Medtronic). If dilatation was not successful (>30% stenosis, perforation, occlusive or flow limiting dissection) prolonged inflation should be attempted after which bail-out stenting with a bare nitinol stent is allowed in case of inadequate results.
The regular follow-up is necessary to monitor the condition of the patient and the results of the procedure. The patients will be invited for the following required follow-up visits at 1,6 and 12 months. During these visit the following data will be collected: medication record, physical exam, target limb ABI and Rutherford classification, duplex ultrasound of target vessel, walking impairment questionnaire and possible adverse events.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||302 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||The patients will be assigned at random to one of two treatment groups namely the Passeo-18 Lux or the IN.PACT Admiral treatment group.|
|Masking Description:||a single-blind masking will be implemented. The patient won't know which DCB he/she received.|
|Official Title:||A Randomized Controlled Non-inferiority Trial to Evaluate the Safety and Efficacy of the Passeo-18 Lux Drug-coated Balloon of Biotronik in the Treatment of Subjects With Stenotic, Restenotic or Occlusive Lesions of the Femoropopliteal Artery Compared to the Medtronic IN.PACT Admiral Drug-coated Balloon|
|Estimated Study Start Date :||June 1, 2019|
|Estimated Primary Completion Date :||June 1, 2021|
|Estimated Study Completion Date :||June 1, 2021|
Experimental: Passeo-18 Lux treatment group
These patients will be treated with the Passeo-18 Lux (Biotronik).
Device: Passeo-18 Lux treatment group
Percutaneous endovascular angioplasty with the Passeo-18 lux
Active Comparator: IN.PACT Admiral treatment group
These patients will be treated with the IN.PACT Admiral (Medtronic).
Device: IN.PACT Admiral treatment group
Percutaneous endovascular angioplasty with the IN.PACT Admiral
- freedom from clinically-driven target lesion revascularization (CD-TLR) at 12 months post-procedure [ Time Frame: 12 months post-procedure ]defined as any reintervention at the target lesion due to the following symptoms: drop of ABI >20% or ABI >0.15 compared to the post-procedure ABI.
- Safety composite of death, major amputation, and target vessel revascularization (CD-TVR) [ Time Frame: 12 months post-procedure ]composite of (1) freedom from device- and procedure-related death through 30 days post-index procedure, (2) freedom from major target limb amputation (above-the-ankle (ATA)) through 12 months post-procedure and (3) clinically-driven target vessel revascularization (CD-TVR) through 12 months post-index procedure
- acute device success [ Time Frame: Index procedure ]defined as successful delivery, balloon inflation, deflation and retrieval of the intact study device without burst below rated burst pressure
- acute procedural success [ Time Frame: index procedure ]defined as restoration of the target lesion with ≤30% residual stenosis in the final angiogram
- freedom from all causes of death, freedom from major target limb amputation and freedom from CD-TVR through 30 days [ Time Frame: 1 month post-procedure ]freedom from all cause death, major target limb amputation and CD-TVR through 30 days post-procedure
- Sustained clinical improvement [ Time Frame: 6 and 12 months post-procedure ]defined as freedom from major target limb amputation, TVR, worsening target limb Rutherford class (compared to baseline) and decrease in target limb ankle brachial index (ABI) or toe brachial index (TBI) ≥0.15 (compared to baseline)
- freedom from major adverse events [ Time Frame: 6 and 12 months post-procedure ]defined as composite of all-cause death, CD-TVR and major target limb amputation, or thrombosis at the target lesion
- primary patency rate [ Time Frame: 6 and 12 months post-procedure ]defined as a composite of freedom from clinically-driven target lesion revascularization (CD-TLR) and binary restenosis (restenosis defined as duplex ultrasound (DUS) peak systolic velocity ratio (PSVR) ≥2.4 or ≥50% stenosis as assessed by an independent DUS core lab) through 12 months post-index procedure
- freedom from target lesion revascularisation [ Time Frame: 6 and 12 months post-procedure ]defined as a reintervention to maintain or restore the patency in the target lesion. TLR is clinically-driven (CD) when the TLR was needed due to symptoms or drop of ankle brachial index (ABI) of ≥20% or >0.15 when compared to post-procedure
- freedom from target vessel revascularisation [ Time Frame: 6 and 12 months post-procedure ]defined as a reintervention to maintain or restore the patency in the target vessel. TVR is clinically-driven (CD) when the TVR was needed due to symptoms or drop of ankle brachial index (ABI) of ≥20% or >0.15 when compared to post-procedure
- freedom from binary restenosis [ Time Frame: 6 and 12 months post-procedure ]defined as restenosis confirmed by DUS PSVR ≥2.4 or ≥50% stenosis as assessed by independent angiographic and DUS core labs
- freedom from major target limb amputation [ Time Frame: 6 and 12 months post-procedure ]defined as an amputation above the ankle in the target limb
- freedom from thrombosis at target lesion [ Time Frame: 6 and 12 months post-procedure ]freedom from thrombosis at target lesion
- change in walking impairment questionnaire score from baseline to 6 and 12 months [ Time Frame: 6 and 12 months post-procedure ]
change in walking impairment questionnaire (WIQ) score from baseline to 6 and 12 months.
The WIQ consists of 6 sections each consisting of multiple questions. Each question is scored from 0 to 4 (0 meaning a lot of problems and 4 no problems at all). The scores per section are summed up and recalculated to percentages (100% meaning very good and 0% meaning very bad). All the sections are averaged to give the final WIQ-score.
- change in target limb rutherford class from baseline to 6 and 12 months [ Time Frame: 6 and 12 months post-procedure ]change in target limb rutherford class from baseline to 6 and 12 months
- change in target limb resting ABI or TBI from baseline to 6 and 12 months [ Time Frame: 6 and 12 months post-procedure ]change in target limb resting ABI or TBI from baseline to 6 and 12 months
- freedom from all causes of death [ Time Frame: 6 and 12 months post-procedure ]freedom from all causes of death
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): NCT03884257
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