DEFINITIVE AR Two Year Follow-up Extension Study

Directional AthErectomy Followed by a PaclItaxel-Coated BalloN to InhibiT RestenosIs and Maintain Vessel PatEncy: A Pilot Study of Anti-Restenosis Treatment - Two Year Follow-up Extension Study

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02363894

Enrollment

Registered

2015-02-16

Start date

2015-03-31

Completion date

2015-06-30

Last updated

2016-02-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Peripheral Arterial Disease

Brief summary

The purpose of this DEFINITIVE AR Two Year Follow-up Extension Study is to gather data to assess and estimate the long term effect of treating a vessel with plaque excision (PE) in combination with paclitaxel-coated balloon angioplasty (PTX PTA) compared to treatment with PTX PTA alone.

Interventions

None listed

Study design

Observational model

COHORT

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* Was a subject in DEFINITIVE AR I * Is able and willing to provide written informated consent prior to study specific data collection.

Exclusion criteria

* Withdrew consent in DEFINITIVE AR I. * Was reported dead during DEFINITIVE AR I.

Design outcomes

Primary

Measure	Time frame
Major Adverse Event Rate	2 years

Outcome results