NCT02850107: REALITY

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

Completed NA Last updated 19 October 2020

What this trial tests

NA trial testing Medtronic HawkOne® or TurboHawk™ in Peripheral Vascular Disease in 102 participants. Completed in 16 June 2020.

Timeline

1 June 2016

Primary endpoint
16 June 2020

16 June 2020

Quick facts

Lead sponsor	VIVA Physicians
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	102
Start date	1 June 2016
Primary completion	16 June 2020
Estimated completion	16 June 2020
Sites	7 locations across United States

Drugs / interventions tested

• Medtronic HawkOne® or TurboHawk™
• Medtronic IN.PACT® Admiral® DCB
• Medtronic Spider™ Distal Protection Device (DPD)
• Volcano Visions® PV .014" IVUS catheter
• Nitinol Stent Placement

Conditions studied

• Peripheral Vascular Disease — all drugs for Peripheral Vascular Disease →

Sponsor

VIVA Physicians

Who can join

18 and older, any sex, with Peripheral Vascular Disease. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

3 peer-reviewed publications reference this trial (live from Europe PMC):

1. Three-Year Sustained Clinical Efficacy of Drug-Coated Balloon Angioplasty in a Real-World Femoropopliteal Cohort.
   Torsello G, Stavroulakis K, Brodmann M, Micari A, et al · · 2020 · cited 55× · PMID 32583749 · DOI 10.1177/1526602820931477
2. Directional atherectomy before paclitaxel coated balloon angioplasty in complex femoropopliteal disease: The VIVA REALITY study.
   Rocha-Singh KJ, Sachar R, DeRubertis BG, Nolte-Ernsting CCA, et al · · 2021 · cited 42× · PMID 34080792 · DOI 10.1002/ccd.29777
3. Vascular calcification: from the perspective of crosstalk.
   Yang S, Zeng Z, Yuan Q, Chen Q, et al · · 2023 · cited 13× · PMID 37851172 · DOI 10.1186/s43556-023-00146-y