Peripheral Vascular DiseasesNCT05334095
Angio-seal VIP Versus Perclose ProGlide for Closure of the Femoral Artery in Peripheral Vascular Disease
A study testing Perclose ProGlide and Angio-seal VIP in people with Peripheral Vascular Diseases and Percutaneous Intervention Via Femoral Artery, run by Xiongjing Jiang at 1 site in China.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Peripheral Vascular Diseases, Percutaneous Intervention Via Femoral Artery
- What is being tested?
- Perclose ProGlide and Angio-seal VIP
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 1,062 participants
- Where
- 1 siteChina
- Study dates
- 20 Aug 2019to 1 Sep 2022
- 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 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Fuwai Hospital, National Center for Cardiovascular Disease, Chinese Academy of Medical Sciences and Peking Union Medical College
Beijing, Beijing Municipality, 100037
Xiongjing Jiang, MD, 86-1088322385, jxj103@hotmail.com
Hui Dong, MD
About this study
Official title: 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).
Read the 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).
- Being tested
- Perclose ProGlide, Angio-seal VIP
- Keywords
- Peripheral Vascular Diseases, closure device, Femoral Artery
- Medical subject headings
- Peripheral Vascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Perclose ProGlideDevice
After peripheral vascular diagnostic and interventional procedures, patients are randomized to receive Perclose ProGlide.
Angio-seal VIPDevice
After peripheral vascular diagnostic and interventional procedures, patients are randomized to receive Angio-seal VIP
| Study group | Role | What they receive |
|---|---|---|
| Perclose ProGlide | Active comparator | Perclose ProGlide 6F Suture-Mediated Closure (SMC) System Receives: Device: Perclose ProGlide |
| Angio-seal VIP | Placebo comparator | Angio-seal VIP Vascular Closure Device Receives: Device: Angio-seal VIP |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of the device successfully deployed and absence of the major vascular complications necessitating aggressive treatments (surgical or percutaneous repair etc.) at 30 days
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:
- Vascular injury related to access site requiring surgical or percutaneous intervention, or ultrasound guided compression, or thrombin injection.
- 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.
- haemorrhage related to access site requiring transfusion, or haemoglobin decreased by ≥5g/dl or hematocrit (HCT) decreased by ≥15%
- Infection requiring a hospitalization extended for more than 24 hours or a new hospitalization or treatment with intravenous antibiotics.
- Nerve injury related to access site which is permanent or requires surgery.
Measured: 30 days post procedure
Secondary outcomes (5)
Minor ipsilateral access site complications at 30 days and generally no aggressive treatment is required
Minor ipsilateral access site vascular complications included:
- Access site pseudoaneurysm or AV fistula documented by ultrasound, neither surgical nor percutaneous intervention is required.
- Post-discharge access site-related haemorrhage requiring ≥ 30 minutes manual compression to re-achieve hemostasis.
- Lower extremity arterial stenosis attributed to arterial access or closure, whereas neither surgical nor percutaneous intervention is required.
- 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%.
- Access site hematoma ≥ 6 cm, neither blood transfusion nor surgical intervention is required.
- Localized access site infection treated with intramuscular or oral antibiotics.
- Transient access site-related nerve injury.
Measured: 30 days post procedure
Incidence at 180 days of the composite endpoint of major vascular complications necessitating aggressive treatments (surgical or percutaneous repair etc.)
Major vascular complications include:
- Vascular injuries related to access site requiring surgical or percutaneous intervention, or ultrasound guided compression, or thrombin injection.
- 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.
- Bleeding related to access site requiring transfusion or haemoglobin decreased by ≥5g/dl or hematocrit (HCT) decreased by ≥15%
- Infection requiring a extended hospitalization for more than 24 hours or a new hospitalization or treatment with intravenous antibiotics.
- Nerve injury related to access site is permanent or requires surgery.
Measured: 180 days post procedure
Deployment procedure time
Deployment procedure time was defined as elapsed time from the first skin break to final closure (skin to skin time)
Measured: within 24 hours of device deployment
Time to haemostasis from removing the sheath until haemostasis
Haemostasis is considered as insignificant bleeding on the bandage or small continuous oozing, manual compression is no longer needed or less than 5 minutes.
Measured: within 24 hours of device deployment
Patients' comfort level during the deployment of the closure device using the visual analog scale (VAS)
0 cm means no pain, while 10 cm means the worst imaginable pain or the worst pain one had experienced
Measured: within 5 minutes of device deployment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Apr 2022
- Study start20 Aug 2019
- Primary completion1 Jun 2022 (estimated)
- Study completion1 Sep 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Peripheral Vascular DiseasesStudies of the same condition, open and under way.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1,062 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Xiongjing Jiang
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Xiongjing Jiang, Chinese Academy of Medical Sciences, Fuwai Hospital
- Investigators
- Xiongjing Jiang, MD, Principal investigator, Fuwai Hospital, National Center for Cardiovascular Disease
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05334095
- Sponsor's protocol ID
- 2019-ZX09
- Status last verified
- Apr 2022
- First submitted
- 6 Apr 2022
- Last updated
- 19 Apr 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 19 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Angio-seal VIP Versus Perclose ProGlide for Closure of the Femoral Artery in Peripheral Vascular Disease: a Prospective Single-center Randomized Non-inferiority Trial
- ClinicalTrials.gov ID
- NCT05334095
- Acronym / sponsor ID
- 2019-ZX09
- Keywords
- Peripheral Vascular Diseases, closure device, Femoral Artery
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 1,062 participants (estimated)
- Lead sponsor
- Xiongjing JiangUniversity, hospital or other
- Study start
- 20 Aug 2019 (actual)
- Primary completion
- 1 Jun 2022 (estimated)
- Study completion
- 1 Sep 2022 (estimated)
- First posted
- 19 Apr 2022 (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.
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).
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Perclose ProGlide | Active comparator | Device: Perclose ProGlidePerclose ProGlide 6F Suture-Mediated Closure (SMC) System |
| Angio-seal VIP | Placebo comparator | Device: Angio-seal VIPAngio-seal VIP Vascular Closure Device |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
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 |
|---|---|---|
| Perclose ProGlideAfter peripheral vascular diagnostic and interventional procedures, patients are randomized to receive Perclose ProGlide. | Device | Perclose ProGlide |
| Angio-seal VIPAfter peripheral vascular diagnostic and interventional procedures, patients are randomized to receive Angio-seal VIP | Device | Angio-seal VIP |
Primary outcome
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.
5 secondary outcomes
Minor ipsilateral access site complications at 30 days and generally no aggressive treatment is required
Time frame: 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
Deployment procedure time
Time frame: within 24 hours of device deployment
Time to haemostasis from removing the sheath until haemostasis
Time frame: 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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Apr 2022.
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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.
Xiongjing Jiang, MD principal investigator
Fuwai Hospital, National Center for Cardiovascular Disease
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Perclose ProGlide and Angio-seal VIP in people with Peripheral Vascular Diseases and Percutaneous Intervention Via Femoral Artery, run by Xiongjing Jiang at 1 site in China.
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 4 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 19 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. 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. Some participants in this study may receive a placebo. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Xiongjing Jiang, MD (+861088322385, jxj103@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 19 Apr 2022; AzTrials last refreshed its copy on 7 Nov 2026.