Atherectomy Followed by a Drug Coated Balloon to Treat Peripheral Arterial Disease (DEFINITIVE AR)

This study has been completed.
Sponsor:
Collaborator:
MEDRAD, Inc.
Information provided by (Responsible Party):
Covidien
ClinicalTrials.gov Identifier:
NCT01366482
First received: June 2, 2011
Last updated: July 23, 2014
Last verified: July 2014
  Purpose

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.


Condition Intervention Phase
Peripheral Arterial Disease,
Claudication
Device: Cotavance Drug-Eluting Balloon
Device: TurboHawk/SilverHawk Device followed by a Cotavance Drug-Eluting Balloon
Device: TurboHawk/SilverHawk Device followed by a Cotavance Drug-Eluting Balloon (N=25)
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Directional AthErectomy Followed by a PaclItaxel-Coated BallooN to InhibiT RestenosIs and Maintain Vessel PatEncy: A Pilot Study of Anti-Restenosis Treatment

Resource links provided by NLM:


Further study details as provided by Covidien:

Primary Outcome Measures:
  • Target Lesion Percent Stenosis [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Enrollment: 121
Study Start Date: July 2011
Study Completion Date: May 2014
Primary Completion Date: May 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Drug-eluting balloon Device: Cotavance Drug-Eluting Balloon
Treatment with a Paclitaxel-coated angioplasty balloon (without preceding plaque excision)
Experimental: Plaque excision followed by a drug-eluting balloon Device: TurboHawk/SilverHawk Device followed by a Cotavance Drug-Eluting Balloon
Plaque excision followed by treatment with a paclitaxel-coated angioplasty balloon
Experimental: Non-Randomized Arm (severely calcified lesions)
Subjects with severe calcification will be assigned to a non-randomized arm and treated with plaque excision followed by a drug-eluting balloon
Device: TurboHawk/SilverHawk Device followed by a Cotavance Drug-Eluting Balloon (N=25)
Plaque excision followed by treatment with a paclitaxel-coated angioplasty balloon

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01366482

Locations
Belgium
Imelda Hospital
Bonheiden, Belgium
Sponsors and Collaborators
Covidien
MEDRAD, Inc.
Investigators
Principal Investigator: Professor Thomas Zeller Herz-Zentrum Bad Krozingen Germany
Principal Investigator: Professor Gunnar Tepe Klinikum Rosenheim Germany
  More Information

No publications provided

Responsible Party: Covidien
ClinicalTrials.gov Identifier: NCT01366482     History of Changes
Other Study ID Numbers: P-4941
Study First Received: June 2, 2011
Last Updated: July 23, 2014
Health Authority: Belgium: Federal Agency for Medicinal Products and Health Products
Germany: Federal Institute for Drugs and Medical Devices
Poland: Ministry of Health
Switzerland: Swissmedic

Keywords provided by Covidien:
Peripheral arterial disease,
claudication,
atherectomy,
plaque excision,
drug-coated balloon
drug-eluting balloon

Additional relevant MeSH terms:
Peripheral Arterial Disease
Peripheral Vascular Diseases
Atherosclerosis
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases
Paclitaxel
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on July 29, 2014