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Completed

NCT Number: NCT02462005

Treatment of Femoro-popliteal Atherosclerotic Lesions Using the Ranger Paclitaxel Coated Balloon Catheter. All Comers Registry.

A total of up to 250 patients from an all-comers patient population with infrainguinal atherosclerotic disease who are implanted or scheduled for an implant with a Ranger Drug coated balloon.

Interim analysis will be carried out for every 50 subjects enrolled.

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Key information

Conditions

Atherosclerotic Disease

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Klinikum Hochsauerland, Karolinen-Hospital, Arnsberg, Germany

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age ≥ 18 years.
  • Patient must be willing to sign a a patient informed consent form.
  • Patient with de novo, restenotic or reoccluded lesions in the infrainguinal .arteries implanted or scheduled for an implant with a Ranger Drug coated balloon.
  • Target vessel reference diameter 2.5 to 8 mm.

Exclusion criteria

  • Subjects pregnant or planning to become pregnant during the course of the study.
  • Life expectancy of less than 1 year.
  • Known allergy to concomitant medication, contrast agents (that cannot be medically managed), anti-platelet, anti-coagulant or thrombolytic medications. Subject enrolled in another study that has not reached its primary endpoint at the time of enrolment.

Treatment and study plan

Primary outcomes

  1. Clinical primary endpoint: Major Adverse Events (MAE) defined as composite of freedom from device- and procedure-related mortality through 30 days, freedom from major target limb amputation and TLR within 6 months post-index procedure.

    Time frame: 6 Months

  2. Performance primary endpoint: Primary patency at 12 months, defined as freedom from > 50% restenosis with no clinically-driven reintervention

    Time frame: 12 Months

Secondary outcomes

  1. Primary patency at 6 and 24 months, defined as freedom from > 50% restenosis with no clinically-driven reintervention

    Time frame: 6 and 24 Months

  2. MAE at 12 and 24 months

    Time frame: 12 and 24 Months

  3. Technical success, defined as successful vascular access and completion of the endovascular procedure and immediate morphological success with ≤ 50% residual stenosis (visual assessment)

    Time frame: Intraoperative

  4. Device success, defined as exact deployment of the device according to the IFU (operator assessment)

    Time frame: Intraoperative

  5. Procedural success, defined as the combination of technical success and device success

    Time frame: Intraoperative

  6. Ankle-Brachial Index (ABI) at 6, 12 and 24 months (and prior to any reintervention)

    Time frame: 6, 12 and 24 months

  7. Improvement of at least one Rutherford class at 6, 12 and 24 months (an prior to any reintervention) compared to the pre-procedure Rutherford classification.

    Time frame: 6, 12 and 24 months

  8. Target Lesion Revascularization (TLR) and Target Vessel Revascularization (TVR) at 6, 12 and 24 months.

    Time frame: 6, 12 and 24 months

  9. Limb salvage, defined as preservation of the treated limb with no need for any amputation at 6, 12 and 24 months.

    Time frame: 6, 12 and 24 months

  10. Improvement of pain score at 6, 12 and 24 months compared to the pre-procedure score

    Time frame: 6, 12 and 24 months

Sponsors and collaborators

Lead sponsor

Klinikum Arnsberg

Other

Collaborators

  • Boston Scientific Corporation

Registry information

Official study title

Ranger DEB All Comers Registry - Treatment of Femoro-popliteal Atherosclerotic Lesions Using the Ranger Paclitaxel Coated Balloon Catheter: An All Comers Registry.

Important dates

Study start
2015
Primary completion
2018
Study completion
2019
First posted
Jun 3, 2015
Registry last updated
Jan 9, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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