Peripheral Arterial DiseaseSTEPNCT03192033
STEP: Proglide® Versus Femoseal®: A Trial to Compare the Efficacy of Arterial Closure Devices Following Endovascular Peripheral Arterial Procedures
A study testing Arterial closure to ensure hemostasis at femoral artery puncture points, Proglide® (Abbott) and Femoseal® (Terumo) in people with Peripheral Arterial Disease, run by Nantes University Hospital at 6 sites in France.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Peripheral Arterial Disease
- What is being tested?
- Arterial closure to ensure hemostasis at femoral artery puncture points, Proglide® (Abbott) and Femoseal® (Terumo)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 233 participants
- Where
- 6 sitesFrance
- Study dates
- 4 Dec 2017to 25 Jun 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 15Show fewer
- 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
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
France6 sites
CHU Angers
Angers
CHU Brest
Brest
CH de Cholet
Cholet
CHD La Roche-sur-Yon
La Roche-sur-Yon
CHU de Poitiers
Poitiers
CHU de Rennes
Rennes
About this study
Official title: STEP: Proglide® Versus Femoseal®: A Randomized Controlled 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.
- Conditions
- Peripheral Arterial Disease
- Being tested
- Arterial closure to ensure hemostasis at femoral artery puncture points, Proglide® (Abbott), Femoseal® (Terumo)
- Medical subject headings
- Peripheral Arterial Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Arterial closure to ensure hemostasis at femoral artery puncture pointsOther
Arterial closure devices used: Proglide® (Abbott)
Proglide® (Abbott)Device
Arterial closure device used: Proglide® (Abbott)
Femoseal® (Terumo)Device
Arterial closure device used: Femoseal® (Terumo)
Arterial closure to ensure hemostasis at femoral artery puncture pointsOther
Arterial closure device used: Femoseal® (Terumo)
| Study group | Role | What they receive |
|---|---|---|
| Arterial closure device used is Proglide® (Abbott) | Other | Not described Receives: Other: Arterial closure to ensure hemostasis at femoral artery puncture points; Device: Proglide® (Abbott) |
| Arterial closure device used is Femoseal® (Terumo) | Other | Not described Receives: Device: Femoseal® (Terumo); Other: Arterial closure to ensure hemostasis at femoral artery puncture points |
What is being measured
The primary outcome is the main question the study is designed to answer.
Technical success defined as hemostasis at the puncture site without major complications.
Measured: Hour 5
Secondary outcomes (6)
Occurrence of major cardio-vascular events
Measured: Month 1
Occurrence of major punctured femoral artery events during the perioperative period
Measured: Hour 5
Occurrence of minor punctured femoral artery events during the perioperative period
Measured: Hour 5
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.
Measured: Hour 5
Quality of life evaluation (EQ-5D)
Measured: Month 1
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
Measured: Month 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jun 2017
- Study start4 Dec 2017
- Primary completion25 Jun 2019
- Study completion25 Jun 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Peripheral Arterial DiseaseStudies of the same condition, open and under way.
- More trials run by Nantes University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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)
- Enrolment
- 233 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nantes University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Philippe CHAILLOU, Doctor, Study chair, Nantes University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03192033
- Sponsor's protocol ID
- RC16_0466
- Acronym
- STEP
- Status last verified
- Jul 2019
- First submitted
- 12 Jun 2017
- Last updated
- 14 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 34386892
Study at a glance
From the registry record, last updated by the sponsor on 14 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- STEP: Proglide® Versus Femoseal®: A Randomized Controlled Trial to Compare the Efficacy of Arterial Closure Devices Following Endovascular Peripheral Arterial Procedures
- ClinicalTrials.gov ID
- NCT03192033
- Acronym / sponsor ID
- STEP / RC16_0466
- Conditions
- Peripheral Arterial Disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 233 participants (actual)
- Lead sponsor
- Nantes University HospitalUniversity, hospital or other
- Study start
- 4 Dec 2017 (actual)
- Primary completion
- 25 Jun 2019 (actual)
- Study completion
- 25 Jun 2019 (actual)
- First posted
- 19 Jun 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- 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)
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (15 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Arterial closure to ensure hemostasis at femoral artery puncture pointsArterial closure devices used: Proglide® (Abbott) | Other | Arterial closure device used is Proglide® (Abbott) |
| Proglide® (Abbott)Arterial closure device used: Proglide® (Abbott) | Device | Arterial closure device used is Proglide® (Abbott) |
| Femoseal® (Terumo)Arterial closure device used: Femoseal® (Terumo) | Device | Arterial closure device used is Femoseal® (Terumo) |
| Arterial closure to ensure hemostasis at femoral artery puncture pointsArterial closure device used: Femoseal® (Terumo) | Other | Arterial closure device used is Femoseal® (Terumo) |
Primary outcome
Technical success defined as hemostasis at the puncture site without major complications.
Time frame: Hour 5
6 secondary outcomes
Occurrence of major cardio-vascular events
Time frame: Month 1
Occurrence of major punctured femoral artery events during the perioperative period
Time frame: Hour 5
Occurrence of minor punctured femoral artery events during the perioperative period
Time frame: Hour 5
Walking ability
Time frame: Hour 5
Quality of life evaluation (EQ-5D)
Time frame: Month 1
Cost-Outcome Ratio of patient care with FemoSeal® (St Jude) and Proglide® (Abbott)
Time frame: Month 1
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Sep 2026.
- Results publication: PubMed 34386892Goueffic 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Philippe CHAILLOU, Doctor study chair
Nantes University Hospital
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Arterial closure to ensure hemostasis at femoral artery puncture points, Proglide® (Abbott) and Femoseal® (Terumo) in people with Peripheral Arterial Disease, run by Nantes University Hospital at 6 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Technical success defined as hemostasis at the puncture site without major complications. (time frame: Hour 5). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03192033, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Sep 2026.