Innova Breeze®-Based Roadmap for Peripheral Arterial Disease

NCT ID: NCT05189522

Last Updated: 2023-03-07

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-01-26
• Study Completion Date: 2024-05-25

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.

Conditions

Peripheral Arterial Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Innova Breeze®-based roadmap

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.

Group Type: EXPERIMENTAL

Innova Breeze®-based roadmap

Intervention Type: DEVICE

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

control group

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.

Group Type: OTHER

Control Group

Intervention Type: OTHER

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.

Interventions

Innova Breeze®-based roadmap

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: DEVICE

Control Group

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: OTHER

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Fondation Hôpital Saint-Joseph

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Yann GOUEFFIC, MD

Role: PRINCIPAL_INVESTIGATOR

Fondation Hôpital Saint-Joseph

Locations

Groupe Hospitalier Paris Saint-Joseph

Paris, , France

Site Status: RECRUITING

Countries

France

Central Contacts

Yann GOUEFFIC, MD

Role: CONTACT

ygoueffic@ghpsj.fr

144126172 ext. +33

Helene BEAUSSIER, PharmD, PhD

Role: CONTACT

crc@ghpsj.fr

144127883 ext. +33

Facility Contacts

Yann GOUEFFIC, MD

Role: primary

ygoueffic@ghpsj.fr

144126172 ext. +33

References

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Other Identifiers

IBREED

Identifier Type: -

Identifier Source: org_study_id