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

Primary Purpose

Peripheral Arterial Disease, Claudication

Status
Completed
Phase
Not Applicable
Locations
Belgium
Study Type
Interventional
Intervention
Cotavance Drug-Eluting Balloon
TurboHawk/SilverHawk + Cotavance Drug-Eluting Balloon
TurboHawk/SilverHawk + Cotavance Drug-Eluting Balloon
Sponsored by
Medtronic Endovascular
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Peripheral Arterial Disease focused on measuring Peripheral arterial disease,, claudication,, atherectomy,, plaque excision,, drug-coated balloon, drug-eluting balloon

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Imelda Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

Drug-eluting balloon

Plaque excision + drug-eluting balloon

Severely Ca++ Group

Arm Description

Subjects are randomized to have a lesion treated with a paclitaxel-coated balloon Intervention: Cotavance Drug-Eluting Balloon

Subjects are randomized to have a lesion treated with plaque excision (PE) followed by treatment with a paclitaxel-coated balloon Intervention: SilverHawk/TurboHawk + Cotavance Drug-Eluting Balloon

Subjects with a severely calcified lesion will be assigned to a non-randomized arm and treated with plaque excision followed by a drug-eluting balloon Intervention: SilverHawk/TurboHawk + Cotavance Drug-Eluting Balloon

Outcomes

Primary Outcome Measures

Target Lesion Percent Stenosis

Secondary Outcome Measures

Full Information

First Posted
June 2, 2011
Last Updated
May 24, 2019
Sponsor
Medtronic Endovascular
Collaborators
MEDRAD, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT01366482
Brief Title
Atherectomy Followed by a Drug Coated Balloon to Treat Peripheral Arterial Disease
Acronym
DEFINITIVE AR
Official Title
Directional AthErectomy Followed by a PaclItaxel-Coated BallooN to InhibiT RestenosIs and Maintain Vessel PatEncy: A Pilot Study of Anti-Restenosis Treatment
Study Type
Interventional

2. Study Status

Record Verification Date
May 2019
Overall Recruitment Status
Completed
Study Start Date
July 2011 (undefined)
Primary Completion Date
May 2014 (Actual)
Study Completion Date
May 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Medtronic Endovascular
Collaborators
MEDRAD, Inc.

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Peripheral Arterial Disease, Claudication
Keywords
Peripheral arterial disease,, claudication,, atherectomy,, plaque excision,, drug-coated balloon, drug-eluting balloon

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
121 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Drug-eluting balloon
Arm Type
Experimental
Arm Description
Subjects are randomized to have a lesion treated with a paclitaxel-coated balloon Intervention: Cotavance Drug-Eluting Balloon
Arm Title
Plaque excision + drug-eluting balloon
Arm Type
Experimental
Arm Description
Subjects are randomized to have a lesion treated with plaque excision (PE) followed by treatment with a paclitaxel-coated balloon Intervention: SilverHawk/TurboHawk + Cotavance Drug-Eluting Balloon
Arm Title
Severely Ca++ Group
Arm Type
Experimental
Arm Description
Subjects with a severely calcified lesion will be assigned to a non-randomized arm and treated with plaque excision followed by a drug-eluting balloon Intervention: SilverHawk/TurboHawk + Cotavance Drug-Eluting Balloon
Intervention Type
Device
Intervention Name(s)
Cotavance Drug-Eluting Balloon
Intervention Description
Treatment with a paclitaxel-coated angioplasty balloon (without preceding plaque excision)
Intervention Type
Device
Intervention Name(s)
TurboHawk/SilverHawk + Cotavance Drug-Eluting Balloon
Intervention Description
Plaque excision with a SilverHawk or TurboHawk plaque excision device followed by treatment with a paclitaxel-coated angioplasty balloon
Intervention Type
Device
Intervention Name(s)
TurboHawk/SilverHawk + Cotavance Drug-Eluting Balloon
Intervention Description
Plaque excision followed by treatment with a paclitaxel-coated angioplasty balloon
Primary Outcome Measure Information:
Title
Target Lesion Percent Stenosis
Time Frame
1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Professor Thomas Zeller
Organizational Affiliation
Herz-Zentrum Bad Krozingen Germany
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Professor Gunnar Tepe
Organizational Affiliation
Klinikum Rosenheim Germany
Official's Role
Principal Investigator
Facility Information:
Facility Name
Imelda Hospital
City
Bonheiden
Country
Belgium

12. IPD Sharing Statement

Citations:
PubMed Identifier
28916599
Citation
Zeller T, Langhoff R, Rocha-Singh KJ, Jaff MR, Blessing E, Amann-Vesti B, Krzanowski M, Peeters P, Scheinert D, Torsello G, Sixt S, Tepe G; DEFINITIVE AR Investigators. Directional Atherectomy Followed by a Paclitaxel-Coated Balloon to Inhibit Restenosis and Maintain Vessel Patency: Twelve-Month Results of the DEFINITIVE AR Study. Circ Cardiovasc Interv. 2017 Sep;10(9):e004848. doi: 10.1161/CIRCINTERVENTIONS.116.004848.
Results Reference
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Atherectomy Followed by a Drug Coated Balloon to Treat Peripheral Arterial Disease

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