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Clinical Trials/NL-OMON56490
NL-OMON56490
Not yet recruiting
Not Applicable

The Use of Intravascular Ultrasound (IVUS) in Below-The-Knee (BTK) Arteries: A Randomized Controlled Trial. - TIBA

Sint Antonius Ziekenhuis0 sites52 target enrollmentTBD

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Not specified
Sponsor
Sint Antonius Ziekenhuis
Enrollment
52
Status
Not yet recruiting
Last Updated
2 years ago

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
TBD
End Date
TBD
Last Updated
2 years ago
Study Type
Interventional

Investigators

Eligibility Criteria

Inclusion Criteria

  • \* Age \>18 years old;
  • \* CLTI, defined as the presence of PAD in combination with rest pain, gangrene,
  • or a lower limb ulceration \>2 weeks duration;
  • \* Indication for BTK endovascular revascularization, as set by the
  • multidisciplinary team;
  • \* De novo vascular target lesion;
  • \* Written informed consent.

Exclusion Criteria

  • \* Target lesions with a length of \<5 cm or \>20 cm;
  • \* Kawarada Type III pedal arch (no patent dorsalis pedis artery, no patent
  • plantar artery);
  • \* Below\-the\-knee (BTK) critical limb ischemia (CLTI) based on acute thrombosis
  • or thrombo\-emboli;
  • \* Renal insufficiency with a glomerular filtration rate (GFR) of less than 15
  • ml/min but not on dialysis;
  • \* Contrast allergy;
  • \* Non\-salvageable limbs due to extensive tissue necrosis or infection
  • (Rutherford classification of chronic limb ischemia 6 or WiFi classification

Outcomes

Primary Outcomes

Not specified

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