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DiRectional AthErectomy + Drug CoAted BaLloon to Treat Long, CalcifIed FemoropopliTeal ArterY Lesions

NCT02850107 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 102

Last updated 2020-10-19

No results posted yet for this study

Summary

This study is designed to collect information during a procedure that is routine care for treating a blockage in a blood vessel in the upper part of the participant's leg. This study is for data collection reasons to help doctors gain better understanding of the treatment of disease in the blood vessels of the legs. You will be treated with two devices that are routine, or standard of care, for your doctor to treat blockages in the blood vessel of the leg. The treatment is for a blockage or narrowing caused by plaque build-up in the blood vessel. Data will be collected to assess what length of time the blood vessel will be prevented from re-narrowing through twenty-four (24) months after the procedure.

Conditions

  • Peripheral Vascular Disease

Interventions

DEVICE

Medtronic HawkOne® or TurboHawk™

Use of FDA Cleared Directional Atherectomy (DA) Devices. Medtronic HawkOne® Directional Atherectomy System or TurboHawk™ Plaque Excision System. DA followed by DCB will be performed in all enrolled subjects.

DEVICE

Medtronic IN.PACT® Admiral® DCB

FDA Approved Drug Coated Balloon (DCB) Technology. Medtronic IN.PACT® Admiral® DCB will be used after DA.

DEVICE

Medtronic Spider™ Distal Protection Device (DPD)

It is recommended that the Medtronic Spider™ Distal protection device (DPD) be paired with DA when used in complex, calcified lesions (TurboHawk™ IFU).

DEVICE

Volcano Visions® PV .014" IVUS catheter

Lesion IVUS assessment using the Volcano Visions® PV .014" IVUS catheter will be required in all cases.

DEVICE

Nitinol Stent Placement

Only FDA approved nitinol stents can be used if provisional stenting is required.

Sponsors & Collaborators

  • Medtronic

    collaborator INDUSTRY

  • VIVA Physicians

    lead OTHER

Principal Investigators

  • Krishna Singh, MD · VIVA Physicians, Inc.

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-06-01
Primary Completion
2020-06-16
Completion
2020-06-16

Countries

  • United States

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02850107 on ClinicalTrials.gov