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Completed

NCT Number: NCT02648334

Randomized Comparison of DCB for the Treatment of Superficial Femoral and Popliteal Peripheral Artery Disease

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.

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Key information

Conditions

Angioplasty, Balloon Catheterization, Peripheral Femoral Artery Popliteal Artery

Age range

19 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hallym University Sacred Heart Hospital, Anyang, South Korea

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

IN.PACT drug coated balloon

Device

Lutonix Drug Coated Balloon

Device

Primary outcomes

  1. the event rate of composite event

    Time frame: 1 year

    all cause death, revascularization due to amputation or clinical evidence

Secondary outcomes

  1. all cause death

    Time frame: 2 years

  2. cardiac death

    Time frame: 2 years

  3. myocardial infarction

    Time frame: 2 years

  4. stroke

    Time frame: 2 years

  5. amputation of target limb

    Time frame: 2 years

  6. target lesion revascularization

    Time frame: 2 years

  7. The change of Rutherford classification

    Time frame: 2 years

  8. The change of ABI(ankle-brachial index) score

    Time frame: 2 years

  9. MACE

    Time frame: 2 years

    major adverse cardiac event(death, myocardial infarction, stroke)

  10. thrombosis

    Time frame: 2 years

Sponsors and collaborators

Lead sponsor

Seung-Whan Lee, M.D., Ph.D.

Other

Registry information

Official study title

Randomized Comparison of Drug-Coated Balloons for the Treatment of Superficial Femoral and Popliteal Peripheral Artery Disease: Prospective, Multicenter, Randomized, Controlled Trial

Acronym: DCB-SFA

Important dates

Study start
2016
Primary completion
2023
Study completion
2024
First posted
Jan 7, 2016
Registry last updated
Aug 9, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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