Clinical trial NCT03192033: STEP: Proglide® Versus Femoseal®: A Trial to Compare the Efficacy of Arterial Closure Devices Following Endovascular Peripheral Arterial Procedures
Official title: STEP: Proglide® Versus Femoseal®: A Randomized Controlled Trial to Compare the Efficacy of Arterial Closure Devices Following Endovascular Peripheral Arterial Procedures
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Peripheral Arterial Disease
Lead sponsor: Nantes University Hospital
Sponsor class: OTHER
First posted: 2017-06-19
Enrollment: 233
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: A duplex scan guided retrograde femoral puncture is performed followed by the use of a closure arterial device to ensure hemostasis. Patients are randomly assigned to be closed by Proglide® (Abbott) versus Femoseal® (Terumo)
Primary purpose: OTHER

Brief summary: Over the past years, arterial closure systems have tended to replace manual compression to ensure hemostasis at femoral artery puncture points. Arterial closure systems reduce hemostasis and patient immobilization times, thus enabling early resumption of walking. These devices have contributed extensively to the development of outpatient stays for cardiology, vascular and neuro-radiology procedures.

However, main arterial closure devices use different technology to close the arterial puncture point. For some, hemostasis is achieved by sealing the arteriotomy between two discs (an inner and an outer). For others, they are designed to close puncture sites delivering a single monofilament polypropylene suture mediated by needles.

The investigators hypothesis is based on a different efficacy between both arterial closure devices for peripheral arterial disease (PAD) patients.


Eligibility criteria: Inclusion Criteria:

* Age \> 18 years,
* Patient with peripheral arterial disease
* Endovascular examination or treatment compatible with a 5F to 7F sheath
* Walking ability
* Patient affiliated with a social security scheme
* Patient's signed informed consent form

Exclusion Criteria:

* Under-age patient
* Patient of age, but under legal guardianship or care
* Contraindication to endovascular treatment
* Use of a 8F or greater sheath
* Morbidity contraindicating same-day walking
* History of ipsilateral open common femoral artery surgery
* Stent at the puncture site
* Radial or brachial puncture
* Antegrade femoral puncture
* Acute ischemia
* Life expectancy of less than one month
* Patient refusal to take part in the study
* Participation in another therapeutic trial
* Pregnant woman
* Allergy to clopidogrel or aspirin

Primary outcomes:
measure: Technical success defined as hemostasis at the puncture site without major complications.
timeFrame: Hour 5
Secondary outcomes:
measure: Occurrence of major cardio-vascular events
timeFrame: Month 1
measure: Occurrence of major punctured femoral artery events during the perioperative period
timeFrame: Hour 5
measure: Occurrence of minor punctured femoral artery events during the perioperative period
timeFrame: Hour 5
measure: Walking ability
timeFrame: Hour 5
measure: Quality of life evaluation (EQ-5D)
timeFrame: Month 1
measure: Cost-Outcome Ratio of patient care with FemoSeal® (St Jude) and Proglide® (Abbott)
timeFrame: Month 1
Other outcomes:
Locations:
city: Angers
country: France
facility: CHU Angers
city: Brest
country: France
facility: CHU Brest
city: Cholet
country: France
facility: CH de Cholet
city: La Roche-sur-Yon
country: France
facility: CHD La Roche-sur-Yon
city: Poitiers
country: France
facility: CHU de Poitiers
city: Rennes
country: France
facility: CHU de Rennes
Study officials:
affiliation: Nantes University Hospital
name: Philippe CHAILLOU, Doctor
role: STUDY_CHAIR
References:
citation: Goueffic Y, Picquet J, Schneider F, Kaladji A, Marret O, Muller L, Guyomarc'h B, Riche VP, Chaillou P, Guillou M, Nasr B. A Randomized Trial Comparing Polymer Versus Suture-Based Vascular Closure Devices for Arterial Closure Following Lower-Limb Arterial Endovascular Revascularization. Cardiovasc Intervent Radiol. 2021 Dec;44(12):1883-1892. doi: 10.1007/s00270-021-02940-z. Epub 2021 Aug 13.