NCT05617053

Brief Summary

The purpose of this study was to compare the results of directional atherectomy with antirestenotic therapy (DAART technique) and angioplasty/Supera stenting for the treatment of popliteal atherectomy lesions.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
143

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2016

Longer than P75 for all trials

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2016

Completed
6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2022

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2022

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

November 1, 2022

Completed
14 days until next milestone

First Posted

Study publicly available on registry

November 15, 2022

Completed
Last Updated

November 15, 2022

Status Verified

November 1, 2022

Enrollment Period

6 years

First QC Date

November 1, 2022

Last Update Submit

November 8, 2022

Conditions

Popliteal Artery StenosisAtheroma

Keywords

Popliteal arteryDrug-coated balloonSupera stentDirectional atherectomy

Outcome Measures

Primary Outcomes (1)

  • Primary latency 12-months

    primary patency at 12-months follow-up, defined as absence of binary restenosis or reocclusion on duplex ultrasound examination without repeat target lesion interventions

    12 months

Secondary Outcomes (7)

  • Secondary Patency

    12-months

  • Mortality

    12-months

  • Amputation rate

    12-months

  • Clinical status

    12-months

  • ABI measurement

    12-months

  • +2 more secondary outcomes

Study Arms (2)

DAART

Popliteal artery lesion treated by directional atherectomy with anti-restenotic therapy for the treatment of popliteal atherosclerotic lesions.

Device: DAART

ATP/Supera stenting

Angioplasty and Supera stent implantation for the treatment of popliteal atherosclerotic lesions.

Device: ATP/Supera stenting

Interventions

DAARTDEVICE
DAART
ATP/Supera stentingDEVICE
ATP/Supera stenting

Eligibility Criteria

Age18 Years - 99 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

patients with lifestyle limiting intermittent claudication, ischemic rest pain, ischemic ulcers or gangrene (Rutherford class 3 to 6) who presented atherosclerotic lesions in the popliteal artery undergoing endovascular treatment by DAART of PTA/Supera stenting and at least a 12-months of follow-up

You may qualify if:

  • patients with lifestyle limiting intermittent claudication ischemic rest pain, ischemic ulcers or gangrene (Rutherford class 3 to 6) who presented atherosclerotic lesions in the popliteal artery undergoing endovascular treatment by DAART of PTA/Supera stenting and at least a 12-months of follow-up

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Plaque, Atherosclerotic

Condition Hierarchy (Ancestors)

Pathological Conditions, AnatomicalPathological Conditions, Signs and Symptoms

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
NETWORK
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, PhD, MSc, MPGCert

Study Record Dates

First Submitted

November 1, 2022

First Posted

November 15, 2022

Study Start

January 1, 2016

Primary Completion

January 1, 2022

Study Completion

October 1, 2022

Last Updated

November 15, 2022

Record last verified: 2022-11

Data Sharing

IPD Sharing
Will not share