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NCT01366482 Clinical Trial

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

Peripheral Arterial Disease Clinical Trial

— 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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01366482
Other study ID # P-4941
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date July 2011
Est. completion date May 2014

Study information
Verified date May 2019
Source Medtronic Endovascular
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 121
Est. completion date May 2014
Est. primary completion date May 2014
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Device:
• Cotavance Drug-Eluting Balloon
Treatment with a paclitaxel-coated angioplasty balloon (without preceding plaque excision)
• TurboHawk/SilverHawk + Cotavance Drug-Eluting Balloon
Plaque excision with a SilverHawk or TurboHawk plaque excision device followed by treatment with a paclitaxel-coated angioplasty balloon
• TurboHawk/SilverHawk + Cotavance Drug-Eluting Balloon
Plaque excision followed by treatment with a paclitaxel-coated angioplasty balloon

Locations
Country Name City State
Belgium Imelda Hospital Bonheiden

Sponsors (2)
Lead Sponsor Collaborator
Medtronic Endovascular MEDRAD, Inc.

Country where clinical trial is conducted

Belgium, 

Outcome
Type Measure Description Time frame Safety issue
Primary Target Lesion Percent Stenosis 1 year
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