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

Peripheral Arterial Disease Clinical Trial

— STEP  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03192033
• Other study ID #: RC16_0466
• Status: Completed
• Phase: N/A
• Start date: December 4, 2017
• Est. completion date: June 25, 2019

Study information

• Verified date: July 2019
• Source: Nantes University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 233
• Est. completion date: June 25, 2019
• Est. primary completion date: June 25, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Peripheral Arterial Disease
• Peripheral Vascular Diseases

Intervention

Other:
• Arterial closure to ensure hemostasis at femoral artery puncture points
Arterial closure devices used: Proglide® (Abbott)

Device:
• Proglide® (Abbott)
Arterial closure device used: Proglide® (Abbott)
• Femoseal® (Terumo)
Arterial closure device used: Femoseal® (Terumo)

Other:
• Arterial closure to ensure hemostasis at femoral artery puncture points
Arterial closure device used: Femoseal® (Terumo)

Locations

Country	Name	City	State
France	CHU Angers	Angers
France	CHU Brest	Brest
France	CH de Cholet	Cholet
France	CHD La Roche-sur-Yon	La Roche-sur-Yon
France	CHU de Poitiers	Poitiers
France	CHU de Rennes	Rennes

Sponsors (1)

Lead Sponsor	Collaborator
Nantes University Hospital

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Technical success defined as hemostasis at the puncture site without major complications.		Hour 5
Secondary	Occurrence of major cardio-vascular events		Month 1
Secondary	Occurrence of major punctured femoral artery events during the perioperative period		Hour 5
Secondary	Occurrence of minor punctured femoral artery events during the perioperative period		Hour 5
Secondary	Walking ability	Time before restart of the ambulation measured in minutes from when the sheath of the introducer of the arterial closure system is removed and the moment when the patient is able to walk 100 meters without the recurrence of bleeding.	Hour 5
Secondary	Quality of life evaluation (EQ-5D)		Month 1
Secondary	Cost-Outcome Ratio of patient care with FemoSeal® (St Jude) and Proglide® (Abbott)	The measure of effectiveness will be the utility obtained from the EQ-5D quality of life questionnaire	Month 1