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Innova Breeze®-Based Roadmap for Peripheral Arterial Disease (IBREED)

Primary Purpose

Peripheral Arterial Disease

Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Innova Breeze®-based roadmap
Control Group
Sponsored by
Fondation Hôpital Saint-Joseph
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Peripheral Arterial Disease

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Patient ≥ 18 years
  • Patient has a history of symptomatic peripheral arterial disease (Rutherford classification 2-6)
  • Patients with indication of femoropopliteal revascularization according the European guidelines (1)
  • Patient agrees to undergo all protocol required follow-up examinations and requirements at the investigational site
  • French-speaking patient
  • Patient is affiliated to the Social Security or equivalent system
  • Patients is able and willing to give free, informed and express oral consent
  • Iliac and/or below the knee lesions are allowed in combination to femoropopliteal lesions

Exclusion Criteria:

  • Upper limb approach
  • Femoral antegrade approach
  • Pregnant or breastfeeding woman
  • Adult under guardianship or trusteeship
  • Iodinated contrast allergy
  • Reduction in estimated Glomerular Filtration Ratio (eGFR) ≤ 29 ml/min/m2 (11)
  • Patients included in other studies which interact with intraoperative imaging protocols
  • Concurrent participation in an interventional (drug or device) study for which the follow-up period is not complete.
  • Patient under tutorship or curatorship
  • Patient deprived of liberty

Sites / Locations

  • Groupe Hospitalier Paris Saint-JosephRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

Innova Breeze®-based roadmap

control group

Arm Description

An Innova Breeze® bolus chase acquisition is realized prior to the revascularization to assess the lesions of the entire target limb. Guidance to the different lesions is done using a 2D roadmap based on the Innova Breeze® bolus acquisition frames if the patient position has not moved on the table. An Innova Breeze® bolus chase acquisition is realized to assess the final result of the revascularization of the target limb. Both Innova Breeze® bolus chases are required at field of view 30-cm. Finally, the sheath is retrieved and the hemostasis at the puncture site is realized via a manual compression or using a vascular closure device. DSAs are performed with the injector set at 7mL/s and the volume at 7mL (pressure limit 1000psi) for femoropopliteal assessment. Innova Breeze® bolus chase acquisitions are performed with the injector set at 4mL/s and the volume at 24mL (pressure limit 1000psi). An injector with iodinated contrast (50% of dilution) will be used.

2D roadmap guidance is used based on DSA. The treatment of the target lesion is let at the physician discretion. Treatment result of each lesion is checked by a DSA with 1 incidence. After treatment overall limb assessment will be done through multiple staged DSA. Finally, the sheath is retrieved and the hemostasis at the puncture site is realized via a manual compression or using a vascular closure device. DSAs are performed with the injector set at 7mL/s and the volume at 7mL (pressure limit 1000psi) for femoropopliteal assessment. An injector with iodinated contrast (50% of dilution) will be used. For hospitalized patients, three to five days after the procedure, a blood test is performed to assess the eGFR, as part of the usual care of patients. If the patient is no longer hospitalized, at the time of this examination, the investigating physician has given him an order before his discharge to perform this examination in an analysis laboratory.

Outcomes

Primary Outcome Measures

Amount of iodinated contrast volume
This outcome corresponds to the volume of iodinated contrast used at the end of the procedure.

Secondary Outcome Measures

Patient safety in terms of radiation exposure at the end of the procedure
This outcome corresponds to the number of DSA runs.
Staff safety in terms of radiation exposure at the end of the procedure
This outcome corresponds to the Operator exposure (Sv).
Patient clinical improvement
This outcome corresponds to the clinical status (Rutherford stage).
Estimation of renal function post-operative
This outcome corresponds to the Glomerular filtration rate (GFR).
Estimation of renal function at 1 month
This outcome corresponds to the Glomerular filtration rate (GFR)

Full Information

First Posted
December 29, 2021
Last Updated
March 6, 2023
Sponsor
Fondation Hôpital Saint-Joseph
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1. Study Identification

Unique Protocol Identification Number
NCT05189522
Brief Title
Innova Breeze®-Based Roadmap for Peripheral Arterial Disease
Acronym
IBREED
Official Title
Innova Breeze®-Based Roadmap for Peripheral Arterial Disease
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Recruiting
Study Start Date
January 26, 2022 (Actual)
Primary Completion Date
February 10, 2024 (Anticipated)
Study Completion Date
May 25, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Fondation Hôpital Saint-Joseph

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
Over the past decade, interventional endovascular treatment, whenever feasible, has become the first line management in the treatment of lower extremity arterial disease (LEAD) for many indications. Growth of endovascular therapy was based on shorter hospital length of stay and lower complications rates. This minimally invasive procedure allows the revascularization of the lower limbs under fluoroscopy guidance, with injection of iodinated contrast allowing to analyze the arteries. However, many of these patients present renal insufficiency which could be worsened due to the iodinated contrast injections during the endovascular procedure for LEAD. Consequently, the vascular interventionalist should find a way to achieve patient revascularization while minimizing iodinated contrast injections in order to maintain the renal function. The aim of this study is to compare the amount of iodine contrast used during LEAD endovascular revascularization with and without the Innova Breeze® and blended roadmap software.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Peripheral Arterial Disease

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Innova Breeze®-based roadmap
Arm Type
Experimental
Arm Description
An Innova Breeze® bolus chase acquisition is realized prior to the revascularization to assess the lesions of the entire target limb. Guidance to the different lesions is done using a 2D roadmap based on the Innova Breeze® bolus acquisition frames if the patient position has not moved on the table. An Innova Breeze® bolus chase acquisition is realized to assess the final result of the revascularization of the target limb. Both Innova Breeze® bolus chases are required at field of view 30-cm. Finally, the sheath is retrieved and the hemostasis at the puncture site is realized via a manual compression or using a vascular closure device. DSAs are performed with the injector set at 7mL/s and the volume at 7mL (pressure limit 1000psi) for femoropopliteal assessment. Innova Breeze® bolus chase acquisitions are performed with the injector set at 4mL/s and the volume at 24mL (pressure limit 1000psi). An injector with iodinated contrast (50% of dilution) will be used.
Arm Title
control group
Arm Type
Other
Arm Description
2D roadmap guidance is used based on DSA. The treatment of the target lesion is let at the physician discretion. Treatment result of each lesion is checked by a DSA with 1 incidence. After treatment overall limb assessment will be done through multiple staged DSA. Finally, the sheath is retrieved and the hemostasis at the puncture site is realized via a manual compression or using a vascular closure device. DSAs are performed with the injector set at 7mL/s and the volume at 7mL (pressure limit 1000psi) for femoropopliteal assessment. An injector with iodinated contrast (50% of dilution) will be used. For hospitalized patients, three to five days after the procedure, a blood test is performed to assess the eGFR, as part of the usual care of patients. If the patient is no longer hospitalized, at the time of this examination, the investigating physician has given him an order before his discharge to perform this examination in an analysis laboratory.
Intervention Type
Device
Intervention Name(s)
Innova Breeze®-based roadmap
Intervention Description
An Innova Breeze® bolus chase acquisition is realized to assess the final result of the Revascularization of the target limb. Both Innova Breeze® bolus chases are required at field of view 30-cm
Intervention Type
Other
Intervention Name(s)
Control Group
Intervention Description
2D roadmap guidance is used based on DSA. The treatment of the target lesion is let at the physician discretion. Treatment result of each lesion is checked by a DSA with 1 incidence. After treatment overall limb assessment will be done through multiple staged DSA. Finally, the sheath is retrieved and the hemostasis at the puncture site is realized via a manual compression or using a vascular closure device. DSAs are performed with the injector set at 7mL/s and the volume at 7mL (pressure limit 1000psi) for femoropopliteal assessment. An injector with iodinated contrast (50% of dilution) will be used. For hospitalized patients, three to five days after the procedure, a blood test is performed to assess the eGFR, as part of the usual care of patients. If the patient is no longer hospitalized, at the time of this examination, the investigating physician has given him an order before his discharge to perform this examination in an analysis laboratory.
Primary Outcome Measure Information:
Title
Amount of iodinated contrast volume
Description
This outcome corresponds to the volume of iodinated contrast used at the end of the procedure.
Time Frame
Day 1
Secondary Outcome Measure Information:
Title
Patient safety in terms of radiation exposure at the end of the procedure
Description
This outcome corresponds to the number of DSA runs.
Time Frame
Day 1
Title
Staff safety in terms of radiation exposure at the end of the procedure
Description
This outcome corresponds to the Operator exposure (Sv).
Time Frame
Day 1
Title
Patient clinical improvement
Description
This outcome corresponds to the clinical status (Rutherford stage).
Time Frame
Month 1
Title
Estimation of renal function post-operative
Description
This outcome corresponds to the Glomerular filtration rate (GFR).
Time Frame
Day 4
Title
Estimation of renal function at 1 month
Description
This outcome corresponds to the Glomerular filtration rate (GFR)
Time Frame
Month 1

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patient ≥ 18 years Patient has a history of symptomatic peripheral arterial disease (Rutherford classification 2-6) Patients with indication of femoropopliteal revascularization according the European guidelines (1) Patient agrees to undergo all protocol required follow-up examinations and requirements at the investigational site French-speaking patient Patient is affiliated to the Social Security or equivalent system Patients is able and willing to give free, informed and express oral consent Iliac and/or below the knee lesions are allowed in combination to femoropopliteal lesions Exclusion Criteria: Upper limb approach Femoral antegrade approach Pregnant or breastfeeding woman Adult under guardianship or trusteeship Iodinated contrast allergy Reduction in estimated Glomerular Filtration Ratio (eGFR) ≤ 29 ml/min/m2 (11) Patients included in other studies which interact with intraoperative imaging protocols Concurrent participation in an interventional (drug or device) study for which the follow-up period is not complete. Patient under tutorship or curatorship Patient deprived of liberty
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Yann GOUEFFIC, MD
Phone
144126172
Ext
+33
Email
ygoueffic@ghpsj.fr
First Name & Middle Initial & Last Name or Official Title & Degree
Helene BEAUSSIER, PharmD, PhD
Phone
144127883
Ext
+33
Email
crc@ghpsj.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yann GOUEFFIC, MD
Organizational Affiliation
Fondation Hôpital Saint-Joseph
Official's Role
Principal Investigator
Facility Information:
Facility Name
Groupe Hospitalier Paris Saint-Joseph
City
Paris
ZIP/Postal Code
75014
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yann GOUEFFIC, MD
Phone
144126172
Ext
+33
Email
ygoueffic@ghpsj.fr

12. IPD Sharing Statement

Citations:
PubMed Identifier
28886620
Citation
Aboyans V, Ricco JB, Bartelink MEL, Bjorck M, Brodmann M, Cohnert T, Collet JP, Czerny M, De Carlo M, Debus S, Espinola-Klein C, Kahan T, Kownator S, Mazzolai L, Naylor AR, Roffi M, Rother J, Sprynger M, Tendera M, Tepe G, Venermo M, Vlachopoulos C, Desormais I; ESC Scientific Document Group. 2017 ESC Guidelines on the Diagnosis and Treatment of Peripheral Arterial Diseases, in collaboration with the European Society for Vascular Surgery (ESVS): Document covering atherosclerotic disease of extracranial carotid and vertebral, mesenteric, renal, upper and lower extremity arteriesEndorsed by: the European Stroke Organization (ESO)The Task Force for the Diagnosis and Treatment of Peripheral Arterial Diseases of the European Society of Cardiology (ESC) and of the European Society for Vascular Surgery (ESVS). Eur Heart J. 2018 Mar 1;39(9):763-816. doi: 10.1093/eurheartj/ehx095. No abstract available.
Results Reference
background
PubMed Identifier
23915883
Citation
Fowkes FG, Rudan D, Rudan I, Aboyans V, Denenberg JO, McDermott MM, Norman PE, Sampson UK, Williams LJ, Mensah GA, Criqui MH. Comparison of global estimates of prevalence and risk factors for peripheral artery disease in 2000 and 2010: a systematic review and analysis. Lancet. 2013 Oct 19;382(9901):1329-40. doi: 10.1016/S0140-6736(13)61249-0. Epub 2013 Aug 1.
Results Reference
background
PubMed Identifier
34315230
Citation
Criqui MH, Matsushita K, Aboyans V, Hess CN, Hicks CW, Kwan TW, McDermott MM, Misra S, Ujueta F; American Heart Association Council on Epidemiology and Prevention; Council on Arteriosclerosis, Thrombosis and Vascular Biology; Council on Cardiovascular Radiology and Intervention; Council on Lifestyle and Cardiometabolic Health; Council on Peripheral Vascular Disease; and Stroke Council. Lower Extremity Peripheral Artery Disease: Contemporary Epidemiology, Management Gaps, and Future Directions: A Scientific Statement From the American Heart Association. Circulation. 2021 Aug 31;144(9):e171-e191. doi: 10.1161/CIR.0000000000001005. Epub 2021 Jul 28. Erratum In: Circulation. 2021 Aug 31;144(9):e193.
Results Reference
background
PubMed Identifier
25908725
Citation
Criqui MH, Aboyans V. Epidemiology of peripheral artery disease. Circ Res. 2015 Apr 24;116(9):1509-26. doi: 10.1161/CIRCRESAHA.116.303849. Erratum In: Circ Res. 2015 Jun 19;117(1):e12.
Results Reference
background
PubMed Identifier
14732743
Citation
O'Hare AM, Glidden DV, Fox CS, Hsu CY. High prevalence of peripheral arterial disease in persons with renal insufficiency: results from the National Health and Nutrition Examination Survey 1999-2000. Circulation. 2004 Jan 27;109(3):320-3. doi: 10.1161/01.CIR.0000114519.75433.DD. Epub 2004 Jan 19.
Results Reference
background
PubMed Identifier
21728271
Citation
Ungprasert P, Pornratanarangsi S. Correlation between peripheral arterial disease and stage of chronic kidney disease. J Med Assoc Thai. 2011 Feb;94 Suppl 1:S46-50.
Results Reference
background
PubMed Identifier
19522837
Citation
Amighi J, Schlager O, Haumer M, Dick P, Mlekusch W, Loewe C, Bohmig G, Koppensteiner R, Minar E, Schillinger M. Renal artery stenosis predicts adverse cardiovascular and renal outcome in patients with peripheral artery disease. Eur J Clin Invest. 2009 Sep;39(9):784-92. doi: 10.1111/j.1365-2362.2009.02180.x. Epub 2009 Jun 12.
Results Reference
background
PubMed Identifier
28579836
Citation
Andreucci M, Faga T, Serra R, De Sarro G, Michael A. Update on the renal toxicity of iodinated contrast drugs used in clinical medicine. Drug Healthc Patient Saf. 2017 May 22;9:25-37. doi: 10.2147/DHPS.S122207. eCollection 2017.
Results Reference
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Innova Breeze®-Based Roadmap for Peripheral Arterial Disease

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