NCT02648334

Brief Summary

This study evaluates the safety and effectiveness Percutaneous Transluminal Angioplasty(PTA) using Drug-Coated Balloons for the treatment of Superficial Femoral and popliteal peripheral Artery disease.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
443

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Nov 2016

Longer than P75 for not_applicable

Geographic Reach
1 country

14 active sites

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

First Submitted

Initial submission to the registry

January 5, 2016

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 7, 2016

Completed
10 months until next milestone

Study Start

First participant enrolled

November 10, 2016

Completed
6.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 19, 2023

Completed
1.6 years until next milestone

Study Completion

Last participant's last visit for all outcomes

August 7, 2024

Completed
Last Updated

August 9, 2024

Status Verified

August 1, 2024

Enrollment Period

6.2 years

First QC Date

January 5, 2016

Last Update Submit

August 6, 2024

Conditions

Angioplasty, BalloonCatheterization, PeripheralPopliteal ArteryFemoral Artery

Keywords

Drug-Coated BalloonSuperficial Femoral arterypopliteal peripheral Artery

Outcome Measures

Primary Outcomes (1)

  • the event rate of composite event

    all cause death, revascularization due to amputation or clinical evidence

    1 year

Secondary Outcomes (10)

  • all cause death

    2 years

  • cardiac death

    2 years

  • myocardial infarction

    2 years

  • stroke

    2 years

  • amputation of target limb

    2 years

  • +5 more secondary outcomes

Study Arms (2)

IN.PACT drug coated balloon

ACTIVE COMPARATOR

IN.PACT drug coated balloon

Device: IN.PACT drug coated balloon

Lutonix drug coated balloon

EXPERIMENTAL

Lutonix drug coated balloon

Device: Lutonix drug coated balloon

Interventions

IN.PACT drug coated balloonDEVICE
IN.PACT drug coated balloon
Lutonix drug coated balloonDEVICE
Lutonix drug coated balloon

Eligibility Criteria

Age19 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age 19 and above
  • Subject with claudication or critical limb ischemia(Rutherford classification level 2\~5)
  • Subject with total occlusion or stenosis ≥70%(de novo, restenosis)
  • Vessel diameter 4\~6mm
  • Success to guide wire pass
  • Patients who don't have known hypersensitivity or allergy for dual-platelets
  • Willing and able to provide informed written consent

You may not qualify if:

  • Acute stage
  • Acute thrombosis in target limb or target vessel
  • Failure to guide wire pass
  • Distal outflow
  • Lesion with poor inflow
  • Life expectancy ≤ 2 years
  • Allergic to paclitaxel
  • Pregnant or breast feeding woman or disagree with contraception or having children

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (14)

Hallym University Sacred Heart Hospital

Anyang, South Korea

Location

Gyeongsang National University Changwon Hospital

Changwon, South Korea

Location

Kangwon National University Hospital

Chuncheon, South Korea

Location

Chungnam National University Hospital

Daejeon, South Korea

Location

Myongji Hospital

Goyang-si, South Korea

Location

Seoul national university Bundang hospital

Gyeonggi-do, South Korea

Location

Jesushospital

Jeonju, South Korea

Location

Dong-A Medical Center

Pusan, South Korea

Location

Inje University Pusan Paik Hospital

Pusan, South Korea

Location

Veterans Hospital

Pusan, South Korea

Location

Chungnam National University Sejong Hospital

Sejong, South Korea

Location

Asan Medical Center

Seoul, South Korea

Location

Kangbuk Samsung Medical Center

Seoul, South Korea

Location

Veterans Hospital Service Medical Center

Seoul, South Korea

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Division of Cardiology

Study Record Dates

First Submitted

January 5, 2016

First Posted

January 7, 2016

Study Start

November 10, 2016

Primary Completion

January 19, 2023

Study Completion

August 7, 2024

Last Updated

August 9, 2024

Record last verified: 2024-08

Data Sharing

IPD Sharing
Will not share

This is not publicly funded trial.

Locations

KR(14)