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.

NCT03884257 | Active Not Recruiting DMC

• 1 other identifier: BIOPACT-RCT_V1.0_14DEC2018
• Study Type: interventional
• Target: 302
• Locations: 4 countries
• Sites: 14

Brief Summary

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.

Conditions

Peripheral Arterial Disease

Outcome Measures

Primary Outcomes (2)

• freedom from clinically-driven target lesion revascularization (CD-TLR) at 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.

  12 months post-procedure

• Safety composite: number of participants who deceased, had major amputation, or target vessel revascularization (CD-TVR)

  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 or (3) clinically-driven target vessel revascularization (CD-TVR) through 12 months post-index procedure

  12 months post-procedure

Secondary Outcomes (15)

• acute device success

  Index procedure

• acute procedural success

  index procedure

• freedom from all causes of death, freedom from major target limb amputation and freedom from CD-TVR through 30 days

  1 month post-procedure

• Sustained clinical improvement

  6 and 12 months post-procedure

• freedom from major adverse events

  6 and 12 months post-procedure

Study Arms (2)

Passeo-18 Lux treatment group

EXPERIMENTAL

These patients will be treated with the Passeo-18 Lux (Biotronik).

Device: Passeo-18 Lux treatment group

IN.PACT Admiral treatment group

ACTIVE COMPARATOR

These patients will be treated with the IN.PACT Admiral (Medtronic).

Device: IN.PACT Admiral treatment group

Interventions

Passeo-18 Lux treatment group DEVICE

Percutaneous endovascular angioplasty with the Passeo-18 lux

Passeo-18 Lux treatment group

IN.PACT Admiral treatment group DEVICE

Percutaneous endovascular angioplasty with the IN.PACT Admiral

IN.PACT Admiral treatment group

Eligibility Criteria

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

You may qualify if:

• Subject is ≥18 years
• Subject has Rutherford classification 2, 3 or 4
• Subject has provided written informed consent and is willing to comply with study follow- up requirements
• De novo stenotic or occlusive lesion(s) or non-stented restenotic or occlusive lesion(s) occurring \>90 days after prior plain old balloon (POBA) angioplasty or \>180 days after prior DCB treatment
• Target lesion is located between the ostium of the SFA and the end of the P1 segment of the popliteal artery
• Target vessel diameter ≥4mm and ≤7mm
• Target lesion must be stenotic lesion ≤180mm in length (one long lesion or tandem lesions) by investigator's visual estimate or a total occlusion ≤120mm in length by investigator's visual estimate.
• Note: tandem lesions must have a total length of ≤180mm by visual estimate and be separated by ≤30mm
• Target lesion must have angiographic evidence of ≥70% stenosis by investigator's visual estimation
• Successful, uncomplicated crossing of the target lesion occurs when the tip of the guide wire is distal to the target lesion without the occurrence of flow-limiting dissection or perforation and is judged by visual inspection to be within the true lumen. Subintimal dissection techniques may be used if re-entry occurs above the knee (ATK) and without the use of re-entry devices
• Target lesion is located at least 30mm from any stent, if target vessel was previously stented
• After pre-dilatation, the target lesion is ≤50% residual stenosis, absence of a flow-limiting dissection and treatable with available device matrix
• A patent inflow artery free from significant stenosis (≥50% stenosis) as confirmed by angiography
• At least one patent native outflow artery to the ankle or foot, free from significant stenosis (≥50% stenosis) as confirmed by angiography

You may not qualify if:

• Acute limb ischemia
• Patient underwent an intervention involving the target vessel within the previous 90 days
• Patient underwent any lower extremity percutaneous treatment in the ipsilateral limb using a paclitaxel-eluting stent or DCB within the previous 90 days
• Patient underwent a percutaneous transluminal angioplasty (PTA) of the target lesion using a DCB within the previous 180 days
• Women who are pregnant, breast-feeding or intend to become pregnant
• Patient has life expectancy of less than 1 year
• Patient has a known allergy to contrast medium that cannot be adequately pre-medicated
• Patient is allergic to all antiplatelet treatments
• Patient is receiving immunosuppressant therapy
• Patient has platelet count \<100.000/mm3 or \>700.000/mm3
• Patient has history of gastrointestinal haemorrhage requiring a transfusion within 3 months prior to the study procedure
• Patient is diagnosed with coagulopathy that precludes treatment with systemic anticoagulation and/or dual antiplatelet therapy (DAPT)
• Patient has history of stroke within the past 90 days
• Patient has history of myocardial infarction within the past 30 days
• Patient is participating in an investigational drug or medical device study that has not completed primary endpoint(s) evaluation or that clinically interferes with the endpoints from this study, or patient is planning to participate in such study prior to the completion of this study

Sponsors & Collaborators

• ID3 Medical: lead

Study Sites (14)

Medical University of Graz

Graz, Graz, 8036, Austria

Location

Hanusch Hospital

Vienna, Vienna, 1140, Austria

Location

UZA

Antwerp, Antwerp, 2650, Belgium

Location

OLV Ziekenhuis Aalst

Aalst, Oost-Vlaanderen, 9300, Belgium

Location

Imelda Hospital

Bonheiden, 2820, Belgium

Location

A.Z. Sint-Blasius

Dendermonde, 9200, Belgium

Location

Z.O.L.

Genk, 3600, Belgium

Location

R.Z. Heilig Hart

Tienen, 3300, Belgium

Location

CHU Bordeaux

Bordeaux, Nouvelle-Aquitaine, 33300, France

Location

Clinique Pasteur

Toulouse, Occitanie, 3100, France

Location

Clinique Rhône Durance

Avignon, Provence-Alpes-Côte d'Azur Region, 84000, France

Location

Hopital Paris Saint Joseph

Paris, 75014, France

Location

Centre Hospitalier Universitaire Vaudois

Lausanne, Canton of Vaud, CH-1011, Switzerland

Location

Triemlispital Zürich

Zurich, Canton of Zurich, 8063, Switzerland

Location

Related Publications (1)

• Deloose K, Lansink W, Brodmann M, Werner M, Keirse K, Goueffic Y, Verbist J, Maene L, Hendriks J, Brunet J, Ducasse E, Levent K, Sauguet A, Deglise S, Vandael F. Methodology of the BIOPACT RCT, a Multi-center, Randomized, Non-inferiority Trial Evaluating Safety and Efficacy of Passeo-18 Lux Drug-Coated Balloon (DCB) of Biotronik Compared to the Medtronic IN.PACT Admiral DCB in the Treatment of Subjects with Lesions of the Femoropopliteal Artery. Cardiovasc Intervent Radiol. 2022 Dec;45(12):1855-1859. doi: 10.1007/s00270-022-03259-z. Epub 2022 Sep 4.

  PMID: 36058996 DERIVED

MeSH Terms

Conditions

Peripheral Arterial Disease

Condition Hierarchy (Ancestors)

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

Study Officials

• Koen Deloose, MD

  AZ Sint-Blasius

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: a single-blind masking will be implemented. The patient won't know which DCB he/she received.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: March 11, 2019
• First Posted: March 21, 2019
• Study Start: February 18, 2020
• Primary Completion: August 31, 2022
• Study Completion (Estimated): September 1, 2026
• Last Updated: October 16, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

AU (2); CH (2); FR (4); BE (6)