Angiosome Perfusion After Tibial Bypass

U

University Hospital Erlangen

Status and phase

Completed
Phase 2

Conditions

Peripheral Arterial Disease

Treatments

Drug: Indocyanine Green

Study type

Interventional

Funder types

Other

Identifiers

NCT03012750
SPY-Angiosome

Details and patient eligibility

About

Microcirculation should be assessed before and after tibial bypass surgery by intraoperative fluorescence angiography. According to this, the direct and the indirect angiosomes should be compared according to the individual microcirculatory improvement.

Full description

Only patients at CLI stage Rutherford IV to VI with the necessity of tibial Bypass surgery will be included. Macrocirculation is measured by the ankle-brachial index (ABI). In order to assess the skin microcirculation intraoperative fluorescence angiography is used (SPY Elite™, NOVADAQ, Canada). The alteration of microcirculation is compared in direct and indirect revascularized angiosomes by calculation of the fluorescence parameters Ingress (IN) and Ingress rate (InR). Clinical Follow-up investigations will be performed and the wound healing rate is compared between the different revascularization methods.

Enrollment

40 patients

Sex

All

Ages

18 to 99 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Patients at CLI Rutherford stages IV to VI
  • Patients with necessity of tibial Bypass surgery

Exclusion criteria

  • Allergy against indocyanine green
  • Iodine allergy
  • Contrast allergy
  • Penicillin allergy
  • Allergic diathesis
  • Liver insufficiency
  • Pregnancy
  • Hyperthyreosis
  • Pulmonary arterial hypertension

Trial design

40 participants in 1 patient group

foot perfusion
Experimental group
Description:
intravenous application of indocyanine green in patients receiving tibial Bypass surgery
Treatment:
Drug: Indocyanine Green

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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