Physician-Initiated Trial Investigating the Efficacy of Endovascular Treatment of Femoropopliteal Arterial Stenotic Disease With the Biotronik Passeo-18 Lux Drug Releasing Balloon and the Biotronik Pulsar-18 Stent (Comparing With 4EVER Trial Results)

NCT02211664 | Completed Phase 4

• 1 other identifier: FMRP-120130
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 5

Brief Summary

The objective of this clinical investigation is to evaluate the short- and long-term (up to 24 months) outcome of treatment by means of dilation with the Passeo-18 Lux drug releasing balloon and by Pulsar-18 stent implantation in symptomatic (Rutherford 2-4) femoro-popliteal arterial stenotic or occlusive lesions.

Conditions

Peripheral Vascular Disease

Outcome Measures

Primary Outcomes (1)

• Primary patency at 12 months

  Defined as freedom from \>50% restenosis as indicated by an independently verified duplex ultrasound peak systolic velocity ratio (PSVR) \<2.5 in the target vessel with no reintervention.

  12 months

Secondary Outcomes (10)

• Technical success

  1 day post-op

• Procedural success

  1 day post-op

• Number of puncture site complications

  1 day post-op

• Compression time

  1 day post-op

• Primary patency rate at 1-month follow-up

  1 month

Study Arms (1)

Passeo-18-Lux & Pulsar-18

EXPERIMENTAL

The interventional procedure sequence consists of the following steps: 1. pre-dilation of the lesion with a Passeo-18 balloon (mandatory) 2. dilation of the lesion with a Passeo-18 Lux drug releasing balloon (mandatory); a maximum of 2 Passeo-18 Lux balloons can be used per lesion (drug load cannot exceed 12µg) 3. stenting of the lesion with a Pulsar-18 stent (mandatory) 4. post-dilation of the lesion with a Passeo-18 balloon (not mandatory)

Device: Passeo-18 balloon; Device: Passeo-18 Lux drug releasing balloon; Device: Pulsar-18 stent

Interventions

Passeo-18 balloon DEVICE

Passeo-18-Lux & Pulsar-18

Passeo-18 Lux drug releasing balloon DEVICE

Passeo-18-Lux & Pulsar-18

Pulsar-18 stent DEVICE

Passeo-18-Lux & Pulsar-18

Eligibility Criteria

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

You may qualify if:

• De novo lesions located in the femoropopliteal arteries suitable for endovascular treatment
• Patient presenting with a score from 2 to 4 according to the Rutherford classification
• Patient is willing to comply with specified follow-up evaluations at the predefined time intervals time
• Patients is \>18 years old
• Patient understands the nature of the procedure and provides written informed consent, prior to enrollment in the study
• Prior to enrollment, the target lesion was crossed with standard guidewire manipulation
• The target lesions are located within the native SFA: distal point 3 cm above knee joint and 1 cm below the origin of the profunda femoralis
• The target lesion has angiographic evidence of stenosis \>50% or occlusion
• Length of the target lesion is ≤ 19 cm by visual estimation and can be covered with one stent
• Target vessel diameter visually estimated is ≥4 mm and ≤6 mm
• There is angiographic evidence of at least one-vessel-runoff to the foot

You may not qualify if:

• Presence of another stent in the target vessel that was placed during a previous procedure
• Presence of an aortic thrombosis or significant common femoral ipsilateral stenosis
• Previous bypass surgery in the same limb
• Patients contraindicated for antiplatelet therapy, anticoagulants or thrombolytics
• Patients who exhibit persistent acute intraluminal thrombus at the target lesion site
• Perforation at the angioplasty site evidenced by extravasation of contrast medium
• Patients with known hypersensitivity to nickel-titanium
• Patients with uncorrected bleeding disorders
• Female patient with child bearing potential not taking adequate contraceptives or currently breastfeeding
• Life expectancy of less than 12 months
• Ipsilateral iliac artery treatment before target lesion treatment with a residual stenosis \> 30%
• Use of thrombectomy, atherectomy or laser devices during procedure
• Any planned surgical intervention/procedure 30 days after the study procedure
• Any patient considered to be hemodynamically unstable at onset of procedure
• Patient is currently participating in another investigational drug or device study that has not reached the primary endpoint

Sponsors & Collaborators

• Flanders Medical Research Program: lead

Study Sites (5)

University Hospital Antwerp

Edegem, Antwerp, 2650, Belgium

Location

OLV Hospital

Aalst, 9300, Belgium

Location

Imelda Hospital

Bonheiden, 2820, Belgium

Location

AZ Sint-Blasius

Dendermonde, 9200, Belgium

Location

RZ Heilig Hart Hospital

Tienen, 3300, Belgium

Location

Related Publications (1)

• Deloose K, Bosiers M, Peeters P, Verbist J, Maene L, Beelen R, Keirse K, Hendriks J, Lauwers P, Wauters J, Verschueren M. Combining the Passeo-18 Lux Drug-Coated Balloon and the Pulsar-18 Bare Metal Stent: 12- and 24-Month Outcomes of the BIOLUX 4EVER Investigator-Initiated Trial. J Endovasc Ther. 2020 Dec;27(6):936-945. doi: 10.1177/1526602820952413. Epub 2020 Sep 1.

  PMID: 32873131 DERIVED

MeSH Terms

Conditions

Peripheral Vascular Diseases

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 6, 2014
• First Posted: August 7, 2014
• Study Start: June 1, 2014
• Primary Completion: February 1, 2017
• Study Completion: March 1, 2018
• Last Updated: August 13, 2018

Record last verified: 2018-08

Locations

BE (5)