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Completed

NCT Number: NCT01366482

Atherectomy Followed by a Drug Coated Balloon to Treat Peripheral Arterial Disease

The DEFINITIVE AR study is a prospective, multi-center, randomized pilot study evaluating the use of either the TurboHawk™ or SilverHawk® plaque excision systems followed by treatment with the Cotavance™ drug-eluting balloon catheter versus the Cotavance balloon catheter alone in patients with peripheral arterial disease.

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Key information

Conditions

Peripheral Arterial Disease Arterial Occlusive Diseases Arteriosclerosis Atherosclerosis Cardiovascular Diseases Claudication Intermittent Claudication Pathological Conditions, Signs and Symptoms Peripheral Vascular Diseases Signs and Symptoms Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Imelda Hospital

Bonheiden, Belgium

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Rutherford Clinical Category 2-4
  • At least 18 years of age
  • Is able and willing to provide written informed consent prior to study specific procedures

Exclusion criteria

  • Has a life expectancy of less than 24 months
  • Is pregnant, of childbearing potential not taking adequate contraceptive measures, or nursing
  • Has one or more of the contraindications listed in the SilverHawk/ TurboHawk or Cotavance IFUs

Treatment and study plan

Cotavance Drug-Eluting Balloon

Device

Treatment with a paclitaxel-coated angioplasty balloon (without preceding plaque excision)

TurboHawk/SilverHawk + Cotavance Drug-Eluting Balloon

Device

Plaque excision with a SilverHawk or TurboHawk plaque excision device followed by treatment with a paclitaxel-coated angioplasty balloon

Primary outcomes

  1. Target Lesion Percent Stenosis

    Time frame: 1 year

Sponsors and collaborators

Lead sponsor

Medtronic Endovascular

Industry

Collaborators

  • MEDRAD, Inc.

Registry information

Official study title

Directional AthErectomy Followed by a PaclItaxel-Coated BallooN to InhibiT RestenosIs and Maintain Vessel PatEncy: A Pilot Study of Anti-Restenosis Treatment

Acronym: DEFINITIVE AR

Important dates

Study start
2011
Primary completion
2014
Study completion
2014
First posted
Jun 6, 2011
Registry last updated
May 29, 2019

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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