FREERIDE STUDY, Freeway Paclitaxel Coated Balloon Catheter to Treat Peripheral Artery Disease

October 9, 2013 updated by: Eurocor GmbH

Phase III FREERIDE STUDY Freeway Randomized Angioplasty Study

The primary objective of this prospective, Randomized, Controlled, Multicentre, Open Study is to investigate the inhibition of restenosis by the Paclitaxel-eluting Percutaneous transluminal angioplasty (PTA) balloon Freeway versus PTA alone in the treatment of de-novo occluded, stenotic or reoccluded, restenotic superficial femoral (SFA) or popliteal arteries.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
280

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • Austria
      • Graz, Austria
        • Recruiting
        • Medical University
  • Colombia
      • Cali, Colombia
        • Recruiting
        • Angiografia de Occidente
  • Germany
      • Bad Krozingen, Germany
        • Recruiting
        • Herzzentrum Bad Krozingen
      • Berlin, Germany, 10365
        • Recruiting
        • Ev. Krankenhaus Königin Elisabeth Herzberge
      • Berlin, Germany
        • Not yet recruiting
        • Berlin-Gefäßzentrum
      • Bremen, Germany
        • Recruiting
        • Klinikum Links der Weser
      • Dresden, Germany
        • Recruiting
        • Krankenhaus Dresden-Friedrichstadt
      • Leipzig, Germany
        • Recruiting
        • Medical University
      • Münster, Germany
        • Recruiting
        • Universitatsklinikum Munster
      • Tuebingen, Germany
        • Recruiting
        • Universitätsklinikum Tuebingen
  • Hungary
      • Budapest, Hungary
        • Active, not recruiting
        • Semmelweis Universitíy
  • Italy
      • Abano Terme, Italy
        • Recruiting
        • Policlinico Abano Terme
      • Cotignola, Italy
        • Recruiting
        • Maria Cecilia Hospital
      • Mercogliano, Italy
        • Not yet recruiting
        • Casa di Cura Privata Montevergine S.p.A.
      • Torino, Italy
        • Recruiting
        • San Giovanni Battista "Molinette"
      • Torino, Italy
        • Recruiting
        • San Giovanni Bosco Hospital
  • Spain
      • San Sebastian, Spain
        • Recruiting
        • Hospital Universitario de Donostia

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Male or non-pregnant female (> 18 years of age) with symptomatic ischemia, requiring treatment of SFA or PI segment ( 2-5 of Rutherford classification)
  • Single and/or multiple de novo occluded, stenotic or reoccluded, restenotic lesion(s) of > 70% , ≤ 15 cm in total length and vessel diameter ≥ 4mm and ≤ 7mm (by visual estimation).
  • Patient provides a signed informed consent and complies with the follow up visits
  • Successful wire crossing of lesion
  • At least one patent (less than 50% stenosis) tibioperoneal run-off vessel

Exclusion Criteria:

  • Gastrointestinal bleeding or coagulopathy contraindicating use of anti-platelet therapy
  • Known intolerance contraindications to study medications and contrast agents, non-controllable with medication.
  • Patient actively participating in another device or drug study
  • History of hemorrhagic stroke within 3 months
  • Previous or planned surgical or intervention procedure within 30 days of index procedure
  • Significant untreated inflow disease or no normal arterial segment proximal of lesion in which duplex ultrasound velocity ratios can be measured
  • Acute or sub-acute thrombus in target vessel
  • Use of adjunctive therapies (i.e. laser, atherectomy, cryoplasty, scoring/cutting balloon)
  • Patients with in-stent restenosis or prior surgery of the target lesion
  • Patients with abdominal aortic, iliaca or popliteal aneurysm (AAA) with ≥ 4cm diameter

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
OTHER: Uncoated PTA balloon catheter
Dilatation with uncoated PTA balloon catheter
Device: Percutaneous transluminal angioplasty with uncoated balloon
ACTIVE_COMPARATOR: Freeway Paclitaxel balloon catheter
Dilatation with Freeway Paclitaxel (3 µg/mm2) coated balloon catheter
Device: Percutaneous transluminal angioplasty with Paclitaxel balloon

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Rate of clinically driven target lesion revascularization
Time Frame: 6 months
6 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
Late lumen loss
Time Frame: 6 months
6 months
Technical success
Time Frame: Baseline
Baseline
Clinical success
Time Frame: Baseline
Baseline
Procedural success
Time Frame: Baseline
Baseline
Ankle Brachial index improvement
Time Frame: 6, 12, 24 months
6, 12, 24 months
Change in Rutherford classification
Time Frame: 6, 12, 24 months
6, 12, 24 months
Walking improvement
Time Frame: 6, 12 ,24 months
6, 12 ,24 months
Rate of minor and major complications
Time Frame: 6,12, 24 months
6,12, 24 months
Rate of target lesion revascularization
Time Frame: 12, 24 months
12, 24 months
Patency rate
Time Frame: 6, 12, 24 months
6, 12, 24 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Eurocor GmbH

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Karl-Ludwig Schulte, Prof. PhD, Ev. Krankenhaus Königin Elisabeth Herzberge. Berlin

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 1, 2011

Primary Completion (ANTICIPATED)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 1, 2014

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 30, 2013

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 9, 2013

First Posted (ESTIMATE)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 10, 2013

Study Record Updates

Last Update Posted (ESTIMATE)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 10, 2013

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 9, 2013

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2013

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • Eur-003

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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