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

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ClinicalTrials.gov Identifier: NCT03192033
Recruitment Status : Completed
First Posted : June 19, 2017
Last Update Posted : July 3, 2019
Sponsor:
Information provided by (Responsible Party):
Nantes University Hospital

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) Not Applicable

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Study Type : Interventional  (Clinical Trial)
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)
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 : December 4, 2017
Actual Primary Completion Date : June 25, 2019
Actual Study Completion Date : June 25, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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)

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)




Primary Outcome Measures :
  1. Technical success defined as hemostasis at the puncture site without major complications. [ Time Frame: Hour 5 ]

Secondary Outcome Measures :
  1. Occurrence of major cardio-vascular events [ Time Frame: Month 1 ]
  2. Occurrence of major punctured femoral artery events during the perioperative period [ Time Frame: Hour 5 ]
  3. Occurrence of minor punctured femoral artery events during the perioperative period [ Time Frame: Hour 5 ]
  4. Walking ability [ Time Frame: 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) [ Time Frame: Month 1 ]
  6. Cost-Outcome Ratio of patient care with FemoSeal® (St Jude) and Proglide® (Abbott) [ Time Frame: Month 1 ]
    The measure of effectiveness will be the utility obtained from the EQ-5D quality of life questionnaire



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03192033


Locations
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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, France
Sponsors and Collaborators
Nantes University Hospital
Investigators
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Study Chair: Philippe CHAILLOU, Doctor Nantes University Hospital

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Responsible Party: Nantes University Hospital
ClinicalTrials.gov Identifier: NCT03192033     History of Changes
Other Study ID Numbers: RC16_0466
First Posted: June 19, 2017    Key Record Dates
Last Update Posted: July 3, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Peripheral Arterial Disease
Peripheral Vascular Diseases
Atherosclerosis
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases
Hemostatics
Coagulants