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Status:

UNKNOWN

Excimer Laser Combined With DCB Compared With Angioplasty Alone in the Treatment of Infrapopliteal Lesions.

Lead Sponsor:

Xuanwu Hospital, Beijing

Conditions:

Critical Limb Ischemia

Infrapopliteal Lesions

Eligibility:

All Genders

18+ years

Phase:

NA

Brief Summary

This study was designed to compare excimer laser combined with drug-coated baloons with angioplasty alone in the treatment of infrapopliteal lesions in patients with critical limb ischemia.

Detailed Description

This is a randomized study comparing excimer laser combined with drug-coated baloons with angioplasty alone in the treatment of infrapopliteal lesions in patients with critical limb ischemia.

Eligibility Criteria

Inclusion

  • The treatment vessel is DeNovo
  • Stenotic (\>50%) or occlusive atherosclerotic disease of infrapopliteal artery(s)
  • Reference target vessel diameter between 2-4.0 mm by visual assessment
  • Documented Rutherford Class 4 or 5 symptomatic critical limb ischemia
  • The patient must be \>18 years of age
  • Life-expectancy of more than 12 months
  • The patient has no child bearing potential or negative serum pregnancy test
  • within 7 days of the index procedure
  • The patient must be willing and able to return to the appropriate follow-up times for the duration of the study
  • The patient must provide written patient informed consent that is approved by the ethics committee
  • Anatomic
  • All inflow lesions successfully (\<30 residual stenosis) treated prior to target lesion treatment during same procedure or according standard of care without unresolved complications
  • At least one angiographically visible target at the ankle for establishment of straight line flow.

Exclusion

  • Patient refusing treatment
  • The target vessel segment diameter is not suitable for available catheter design.
  • Unsuccessfully treated endovascular or bypass( \>30% residual stenosis) proximal ( iliac, superficial femoral, popliteal) inflow limiting arterial/graft stenosis
  • Lesion lies within or adjacent to an aneurysm
  • The patient has a known allergy to heparin, Aspirin or other antiaggregant therapies or a bleeding diatheses or is unable, or unwilling, to tolerate such therapies.
  • The patient has a history of prior life-threatening contrast media reaction.
  • The patient is currently enrolled in another investigational device or drug trial.
  • The patient is currently breast-feeding, pregnant or intends to become pregnant.
  • The patient is unable to provide informed consent
  • The patient has end stage renal disease (currently on any form of dialysis)
  • Known Left Ventricular Ejection Fraction \< 35%
  • The patient has had a myocardial ischemia within 30 days prior to enrollment
  • The patient has had a cardiovascular accident within 90 days prior to enrollment
  • Serum Creatinine \> 150 µmol
  • The patient has a previous bypass in the target limb
  • The patient has a current systemic infection

Key Trial Info

Start Date :

January 1 2019

Trial Type :

INTERVENTIONAL

Allocation :

ESTIMATED

End Date :

December 31 2022

Estimated Enrollment :

184 Patients enrolled

Trial Details

Trial ID

NCT04365075

Start Date

January 1 2019

End Date

December 31 2022

Last Update

October 12 2022

Active Locations (1)

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Page 1 of 1 (1 locations)

1

Yongquan Gu

Beijing, Beijing Municipality, China, 100053