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

• Sponsor: Nantes University Hospital (Other)
• Overall Status: Completed
• CT.gov ID: NCT03192033
• Collaborator: (none)
• Enrollment: 233
• Locations: 6
• Arms: 2
• Actual Duration (Months): 18.7
• Patients Per Site: 38.8
• Patients Per Site Per Month: 2.1

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Peripheral Arterial Disease	Other: Arterial closure to ensure hemostasis at femoral artery puncture points; Device: Proglide® (Abbott); Device: Femoseal® (Terumo); Other: Arterial closure to ensure hemostasis at femoral artery puncture points	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 233 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• 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)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)
• Masking: None (Open Label)
• Primary Purpose: Other
• Official Title: STEP: Proglide® Versus Femoseal®: A Randomized Controlled Trial to Compare the Efficacy of Arterial Closure Devices Following Endovascular Peripheral Arterial Procedures
• Actual Study Start Date: Dec 4, 2017
• Actual Primary Completion Date: Jun 25, 2019
• Actual Study Completion Date: Jun 25, 2019

Arms and Interventions

Arm	Intervention/Treatment
Other: Arterial closure device used is Proglide® (Abbott)	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)
Other: Arterial closure device used is Femoseal® (Terumo)	Device: 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)

Outcome Measures

Primary Outcome Measures

1. Technical success defined as hemostasis at the puncture site without major complications. [Hour 5]

Secondary Outcome Measures

1. Occurrence of major cardio-vascular events [Month 1]

2. Occurrence of major punctured femoral artery events during the perioperative period [Hour 5]

3. Occurrence of minor punctured femoral artery events during the perioperative period [Hour 5]

4. Walking ability [Hour 5]

   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.

5. Quality of life evaluation (EQ-5D) [Month 1]

6. Cost-Outcome Ratio of patient care with FemoSeal® (St Jude) and Proglide® (Abbott) [Month 1]

   The measure of effectiveness will be the utility obtained from the EQ-5D quality of life questionnaire

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	CHU Angers	Angers		France
2	CHU Brest	Brest		France
3	CH de Cholet	Cholet		France
4	CHD La Roche-sur-Yon	La Roche-sur-Yon		France
5	CHU de Poitiers	Poitiers		France
6	CHU de Rennes	Rennes		France

Sponsors and Collaborators

• Nantes University Hospital

Investigators

• Study Chair: Philippe CHAILLOU, Doctor, Nantes University Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Nantes University Hospital
• ClinicalTrials.gov Identifier: NCT03192033
• Other Study ID Numbers: RC16_0466
• First Posted: Jun 19, 2017
• Last Update Posted: Jul 5, 2019
• Last Verified: Jul 1, 2019

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Peripheral Arterial Disease; Peripheral Vascular Diseases; Hemostatics

Study Results

No Results Posted as of Jul 5, 2019