Atherectomy Followed by a Drug Coated Balloon to Treat Peripheral Arterial Disease (DEFINITIVE AR)
This study is ongoing, but not recruiting participants.
Sponsor:
Covidien
Collaborator:
MEDRAD, Inc.
Information provided by (Responsible Party):
Covidien
ClinicalTrials.gov Identifier:
NCT01366482
First received: June 2, 2011
Last updated: May 3, 2013
Last verified: May 2013
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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:
MedlinePlus related topics:
Peripheral Arterial Disease
Drug Information available for:
Paclitaxel
U.S. FDA Resources
Further study details as provided by Covidien:
Primary Outcome Measures:
- Target Lesion Percent Stenosis [ Time Frame: 1 year ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 125 |
| Study Start Date: | July 2011 |
| Estimated Study Completion Date: | June 2014 |
| Estimated Primary Completion Date: | December 2013 (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
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: | May 3, 2013 |
| 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 May 19, 2013