STEP: Proglide® Versus Femoseal®: A Trial to Compare the Efficacy of Arterial Closure Devices Following Endovascular Peripheral Arterial Procedures

NCT03192033 | Completed

• 1 other identifier: RC16_0466
• Study Type: interventional
• Target: 233
• Locations: 1 country
• Sites: 6

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.

Conditions

Peripheral Arterial Disease

Outcome Measures

Primary Outcomes (1)

• Technical success defined as hemostasis at the puncture site without major complications.

  Hour 5

Secondary Outcomes (6)

• Occurrence of major cardio-vascular events

  Month 1

• Occurrence of major punctured femoral artery events during the perioperative period

  Hour 5

• Occurrence of minor punctured femoral artery events during the perioperative period

  Hour 5

• Walking ability

  Hour 5

• Quality of life evaluation (EQ-5D)

  Month 1

Study Arms (2)

Arterial closure device used is Proglide® (Abbott)

OTHER

Other: Arterial closure to ensure hemostasis at femoral artery puncture points; Device: Proglide® (Abbott)

Arterial closure device used is Femoseal® (Terumo)

OTHER

Device: Femoseal® (Terumo); Other: Arterial closure to ensure hemostasis at femoral artery puncture points

Interventions

Arterial closure to ensure hemostasis at femoral artery puncture points OTHER

Arterial closure devices used: Proglide® (Abbott)

Arterial closure device used is Proglide® (Abbott)

Proglide® (Abbott) DEVICE

Arterial closure device used: Proglide® (Abbott)

Arterial closure device used is Proglide® (Abbott)

Femoseal® (Terumo) DEVICE

Arterial closure device used: Femoseal® (Terumo)

Arterial closure device used is Femoseal® (Terumo)

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Nantes University Hospital: lead

Study Sites (6)

CHU Angers

Angers, France

Location

CHU Brest

Brest, France

Location

CH de Cholet

Cholet, France

Location

CHD La Roche-sur-Yon

La Roche-sur-Yon, France

Location

CHU de Poitiers

Poitiers, France

Location

CHU de Rennes

Rennes, France

Location

Related Publications (1)

• 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.

  PMID: 34386892 DERIVED

MeSH Terms

Conditions

Peripheral Arterial Disease

Condition Hierarchy (Ancestors)

Atherosclerosis; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases; Peripheral Vascular Diseases

Study Officials

• Philippe CHAILLOU, Doctor

  Nantes University Hospital

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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)

Study Record Dates

• First Submitted: June 12, 2017
• First Posted: June 19, 2017
• Study Start: December 4, 2017
• Primary Completion: June 25, 2019
• Study Completion: June 25, 2019
• Last Updated: July 5, 2019

Record last verified: 2019-07

Data Sharing

• IPD Sharing: Will not share

Locations

FR (6)