Angio-seal VIP Versus Perclose ProGlide for Closure of the Femoral Artery in Peripheral Vascular Disease

April 18, 2022 updated by: Xiongjing Jiang

Angio-seal VIP Versus Perclose ProGlide for Closure of the Femoral Artery in Peripheral Vascular Disease: a Prospective Single-center Randomized Non-inferiority Trial

This study is designed to evaluate the efficacy (device deployment characteristics and performance) and safety (adverse access site related events) of Perclose ProGlide (Abbott Vascular Devices) for femoral access site closure in patients undergoing peripheral vascular diagnostic and interventional procedures in comparison with Angio-seal VIP (St. Jude Medical).

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Prospective, single-center, randomized (1:1), open-label, non-inferiority study in 1062 patients comparing Perclose ProGlide (test device) to the Angio-seal VIP (standard comparator).

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
1062

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Beijing
      • Beijing, Beijing, China, 100037
        • Recruiting
        • Fuwai Hospital, National Center for Cardiovascular Disease, Chinese Academy of Medical Sciences and Peking Union Medical College

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patient is ≥18 and < 85 years of age.
  • Patient is willing to provide written informed consent prior to study device use.
  • Patient is undergoing a peripheral vascular diagnostic and/or interventional procedure via femoral arterial access.
  • Patients' arterial puncture site is in the common femoral artery confirmed by a femoral angiogram, and ≥10mm away from the ostium of the inferior epigastric artery (IEA) and the bifurcation of superficial femoral artery and the profunda femoris artery.

Exclusion Criteria:

  • The femoral access site has been punctured within 30 days, or deployed with a collagen-based hemostasis device within 90 days, or a suture-mediated closure device.
  • Patients having a hematoma, pseudoaneurysm or arteriovenous fistula present prior to sheath removal confirmed by a femoral angiogram.
  • Patients with minimum femoral artery calcium which is fluoroscopically visible at access site or femoral artery diameter stenosis greater than 50%.
  • Ankle-brachial index (ABI) of the ipsilateral limb of access site cannot be measured due to severe peripheral artery disease (PAD).
  • Patients who are pregnant or lactating.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: Perclose ProGlide
Perclose ProGlide 6F Suture-Mediated Closure (SMC) System
Device: Perclose ProGlide
After peripheral vascular diagnostic and interventional procedures, patients are randomized to receive Perclose ProGlide.
Placebo Comparator: Angio-seal VIP
Angio-seal VIP Vascular Closure Device
Device: Angio-seal VIP
After peripheral vascular diagnostic and interventional procedures, patients are randomized to receive Angio-seal VIP

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Incidence of the device successfully deployed and absence of the major vascular complications necessitating aggressive treatments (surgical or percutaneous repair etc.) at 30 days
Time Frame: 30 days post procedure

Deployment procedure success is defined as haemostasis after the delivery and release of a closure device, manual compression is no longer needed or less than 5 minutes, and no more closure devices are needed.

Major vascular complications include:

  1. Vascular injury related to access site requiring surgical or percutaneous intervention, or ultrasound guided compression, or thrombin injection.
  2. New onset lower extremity ischemia attributed to arterial access or closure, and/or the ABI of the ipsilateral limb of access site decreased by ≥0.15 or requiring surgical or additional percutaneous intervention.
  3. haemorrhage related to access site requiring transfusion, or haemoglobin decreased by ≥5g/dl or hematocrit (HCT) decreased by ≥15%
  4. Infection requiring a hospitalization extended for more than 24 hours or a new hospitalization or treatment with intravenous antibiotics.
  5. Nerve injury related to access site which is permanent or requires surgery.
30 days post procedure

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Minor ipsilateral access site complications at 30 days and generally no aggressive treatment is required
Time Frame: 30 days post procedure

Minor ipsilateral access site vascular complications included:

  1. Access site pseudoaneurysm or AV fistula documented by ultrasound, neither surgical nor percutaneous intervention is required.
  2. Post-discharge access site-related haemorrhage requiring ≥ 30 minutes manual compression to re-achieve hemostasis.
  3. Lower extremity arterial stenosis attributed to arterial access or closure, whereas neither surgical nor percutaneous intervention is required.
  4. haemorrhage related to access site with no transfusion required. while, transfusion is required when haemoglobin decreased by <5g/dl or hematocrit (HCT) decreased by <15%.
  5. Access site hematoma ≥ 6 cm, neither blood transfusion nor surgical intervention is required.
  6. Localized access site infection treated with intramuscular or oral antibiotics.
  7. Transient access site-related nerve injury.
30 days post procedure
Incidence at 180 days of the composite endpoint of major vascular complications necessitating aggressive treatments (surgical or percutaneous repair etc.)
Time Frame: 180 days post procedure

Major vascular complications include:

  1. Vascular injuries related to access site requiring surgical or percutaneous intervention, or ultrasound guided compression, or thrombin injection.
  2. New onset lower extremity ischemia that is attributed to arterial access or closure, and the ABI of the ipsilateral limb of access site decreased by ≥0.15 or requiring surgical or additional percutaneous intervention.
  3. Bleeding related to access site requiring transfusion or haemoglobin decreased by ≥5g/dl or hematocrit (HCT) decreased by ≥15%
  4. Infection requiring a extended hospitalization for more than 24 hours or a new hospitalization or treatment with intravenous antibiotics.
  5. Nerve injury related to access site is permanent or requires surgery.
180 days post procedure
Deployment procedure time
Time Frame: within 24 hours of device deployment
Deployment procedure time was defined as elapsed time from the first skin break to final closure (skin to skin time)
within 24 hours of device deployment
Time to haemostasis from removing the sheath until haemostasis
Time Frame: within 24 hours of device deployment
Haemostasis is considered as insignificant bleeding on the bandage or small continuous oozing, manual compression is no longer needed or less than 5 minutes.
within 24 hours of device deployment
Patients' comfort level during the deployment of the closure device using the visual analog scale (VAS)
Time Frame: within 5 minutes of device deployment
0 cm means no pain, while 10 cm means the worst imaginable pain or the worst pain one had experienced
within 5 minutes of device deployment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Xiongjing Jiang

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 20, 2019

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 1, 2022

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 1, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 6, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 18, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 19, 2022

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 19, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 18, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2019-ZX09

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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