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

NCT01366482 | Completed DMC

• 1 other identifier: P-4941
• Study Type: interventional
• Target: 121
• Locations: 1 country
• Sites: 1

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.

Conditions

Peripheral Arterial Disease; Claudication

Keywords

Peripheral arterial disease,; claudication,; atherectomy,; plaque excision,; drug-coated balloon; drug-eluting balloon

Outcome Measures

Primary Outcomes (1)

• Target Lesion Percent Stenosis

  1 year

Study Arms (3)

Drug-eluting balloon

EXPERIMENTAL

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

Device: Cotavance Drug-Eluting Balloon

Plaque excision + drug-eluting balloon

EXPERIMENTAL

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

Device: TurboHawk/SilverHawk + Cotavance Drug-Eluting Balloon

Severely Ca++ Group

EXPERIMENTAL

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

Device: TurboHawk/SilverHawk + Cotavance Drug-Eluting Balloon

Interventions

Cotavance Drug-Eluting Balloon DEVICE

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

Drug-eluting balloon

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

Plaque excision + drug-eluting balloon

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Medtronic Endovascular: lead
• MEDRAD, Inc.: collaborator

Study Sites (1)

Imelda Hospital

Bonheiden, Belgium

Location

Related Publications (1)

• 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.

  PMID: 28916599 DERIVED

MeSH Terms

Conditions

Peripheral Arterial Disease; Intermittent Claudication

Condition Hierarchy (Ancestors)

Atherosclerosis; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases; Peripheral Vascular Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Professor Thomas Zeller

  Herz-Zentrum Bad Krozingen Germany

  PRINCIPAL INVESTIGATOR

• Professor Gunnar Tepe

  Klinikum Rosenheim Germany

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 2, 2011
• First Posted: June 6, 2011
• Study Start: July 1, 2011
• Primary Completion: May 1, 2014
• Study Completion: May 1, 2014
• Last Updated: May 29, 2019

Record last verified: 2019-05

Locations

BE (1)