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

Primary Purpose

Peripheral Vascular Diseases, Percutaneous Intervention Via Femoral Artery

Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Perclose ProGlide
Angio-seal VIP
Sponsored by
Xiongjing Jiang
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Peripheral Vascular Diseases focused on measuring Peripheral Vascular Diseases, closure device, Femoral Artery

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Fuwai Hospital, National Center for Cardiovascular Disease, Chinese Academy of Medical Sciences and Peking Union Medical CollegeRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Perclose ProGlide

Angio-seal VIP

Arm Description

Perclose ProGlide 6F Suture-Mediated Closure (SMC) System

Angio-seal VIP Vascular Closure Device

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.
Deployment procedure time
Deployment procedure time was defined as elapsed time from the first skin break to final closure (skin to skin time)
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.
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

Full Information

First Posted
April 6, 2022
Last Updated
April 18, 2022
Sponsor
Xiongjing Jiang
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1. Study Identification

Unique Protocol Identification Number
NCT05334095
Brief Title
Angio-seal VIP Versus Perclose ProGlide for Closure of the Femoral Artery in Peripheral Vascular Disease
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
Study Type
Interventional

2. Study Status

Record Verification Date
April 2022
Overall Recruitment Status
Recruiting
Study Start Date
August 20, 2019 (Actual)
Primary Completion Date
June 1, 2022 (Anticipated)
Study Completion Date
September 1, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Xiongjing Jiang

4. Oversight

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
Data Monitoring Committee
Yes

5. Study Description

Brief 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 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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Peripheral Vascular Diseases, Percutaneous Intervention Via Femoral Artery
Keywords
Peripheral Vascular Diseases, closure device, Femoral Artery

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
1062 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Perclose ProGlide
Arm Type
Active Comparator
Arm Description
Perclose ProGlide 6F Suture-Mediated Closure (SMC) System
Arm Title
Angio-seal VIP
Arm Type
Placebo Comparator
Arm Description
Angio-seal VIP Vascular Closure Device
Intervention Type
Device
Intervention Name(s)
Perclose ProGlide
Intervention Description
After peripheral vascular diagnostic and interventional procedures, patients are randomized to receive Perclose ProGlide.
Intervention Type
Device
Intervention Name(s)
Angio-seal VIP
Intervention Description
After peripheral vascular diagnostic and interventional procedures, patients are randomized to receive Angio-seal VIP
Primary Outcome Measure Information:
Title
Incidence of the device successfully deployed and absence of the major vascular complications necessitating aggressive treatments (surgical or percutaneous repair etc.) at 30 days
Description
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.
Time Frame
30 days post procedure
Secondary Outcome Measure Information:
Title
Minor ipsilateral access site complications at 30 days and generally no aggressive treatment is required
Description
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.
Time Frame
30 days post procedure
Title
Incidence at 180 days of the composite endpoint of major vascular complications necessitating aggressive treatments (surgical or percutaneous repair etc.)
Description
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.
Time Frame
180 days post procedure
Title
Deployment procedure time
Description
Deployment procedure time was defined as elapsed time from the first skin break to final closure (skin to skin time)
Time Frame
within 24 hours of device deployment
Title
Time to haemostasis from removing the sheath until haemostasis
Description
Haemostasis is considered as insignificant bleeding on the bandage or small continuous oozing, manual compression is no longer needed or less than 5 minutes.
Time Frame
within 24 hours of device deployment
Title
Patients' comfort level during the deployment of the closure device using the visual analog scale (VAS)
Description
0 cm means no pain, while 10 cm means the worst imaginable pain or the worst pain one had experienced
Time Frame
within 5 minutes of device deployment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Xiongjing Jiang, MD
Phone
+861088322385
Email
jxj103@hotmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Xiongjing Jiang, MD
Organizational Affiliation
Fuwai Hospital, National Center for Cardiovascular Disease
Official's Role
Principal Investigator
Facility Information:
Facility Name
Fuwai Hospital, National Center for Cardiovascular Disease, Chinese Academy of Medical Sciences and Peking Union Medical College
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100037
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Xiongjing Jiang, MD
Phone
86-1088322385
Email
jxj103@hotmail.com
First Name & Middle Initial & Last Name & Degree
Hui Dong, MD

12. IPD Sharing Statement

Learn more about this trial

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

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