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Completed

NCT Number: NCT03192033

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

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.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CHU Angers, Angers, France

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Arterial closure to ensure hemostasis at femoral artery puncture points

Other

Arterial closure devices used: Proglide® (Abbott)

Proglide® (Abbott)

Device

Arterial closure device used: Proglide® (Abbott)

Femoseal® (Terumo)

Device

Arterial closure device used: Femoseal® (Terumo)

Primary outcomes

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

    Time frame: Hour 5

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

Nantes University Hospital

Other

Registry information

Official study title

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

Acronym: STEP

Important dates

Study start
2017
Primary completion
2019
Study completion
2019
First posted
Jun 19, 2017
Registry last updated
Jul 5, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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