Use of Indocyanine Green Angiography in Critical Limb Ischemia

NCT02820467 | Unknown Phase 3 DMC

• 1 other identifier: 38RC15.212
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

Investigators conduct a monocentric pilot study with the objective to determine the hemodynamic parameter of fluorescence angiography (slope, amplitude, saturation time ) best correlated with toe pressure in patients with suspicion of critical limb ischemia.

Conditions

Peripheral Arterial Disease

Keywords

Indocyanine; Angiography; Ischemia

Outcome Measures

Primary Outcomes (3)

• Correlation of parameters of fluorescence on time intensity curve ( saturation time (s) with toe pressure (mm hg) assessed by laser doppler

  instantaneous, at the time the exam is performed

• Correlation of parameters of fluorescence on time intensity curve ( amplitude (UA) with toe pressure (mm hg) assessed by laser doppler

  instantaneous, at the time the exam is performed

• Correlation of parameters of fluorescence on time intensity curve ( slope) with toe pressure (mm hg) assessed by laser doppler

  instantaneous, at the time the exam is performed

Secondary Outcomes (3)

• Correlation of parameters of fluorescence on time intensity curve ( saturation time (s) with transcutaneous cutaneous pressure of oxygen (mm Hg)

  instantaneous, at the time the exam is performed

• Correlation of parameters of fluorescence on time intensity curve ( amplitude (UA) with transcutaneous cutaneous pressure of oxygen (mm Hg)

  instantaneous, at the time the exam is performed

• Correlation of parameters of fluorescence on time intensity curve (slope) with transcutaneous cutaneous pressure of oxygen (mm Hg)

  instantaneous, at the time the exam is performed

Study Arms (1)

patients with suspicion of CLI

EXPERIMENTAL

patients presenting with peripheral artery disease and suspicion of critical limb ischemia as assessed by TASK II consensus 30 patients will be enrolled and will benefit of measures of TcPO2, too systolic blood pressure and skin perfusion pressure and in the same time angiography with fluorescence (Indocyanine grey 0.05 mg/kg by intravenous injection

Device: fluorescence angiography

Interventions

fluorescence angiography DEVICE

Injection of indocyanine grey in an antecubital vein at the posology of 0.05 mg/kg

patients with suspicion of CLI

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• patients with peripheral artery disease and suspicion of critical limb ischemia

You may not qualify if:

• pregnant women

Sponsors & Collaborators

• University Hospital, Grenoble: lead

Study Sites (1)

CHU grenoble

Grenoble, France

RECRUITING

Related Publications (21)

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MeSH Terms

Conditions

Peripheral Arterial Disease; Ischemia

Interventions

Fluorescein Angiography

Condition Hierarchy (Ancestors)

Atherosclerosis; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases; Peripheral Vascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Angiography; Diagnostic Techniques, Cardiovascular; Diagnostic Techniques and Procedures; Diagnosis; Diagnostic Techniques, Ophthalmological

Study Officials

• christophe seinturier, MD

  CHU Grenoble france

  PRINCIPAL INVESTIGATOR

Central Study Contacts

christophe seinturier, MD

CONTACT

0033476765547; cseinturier@chu-grenoble.fr

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 10, 2016
• First Posted: July 1, 2016
• Study Start: November 1, 2015
• Primary Completion: August 1, 2017
• Study Completion: August 1, 2017
• Last Updated: March 17, 2017

Record last verified: 2017-03

Locations

FR (1)