Cardiovascular Diseases Clinical Trial
Official title:
A Prospective Randomized Study Comparing Time to Ambulation, Time to Hemostasis and Safety Using a Closure Device Alone an in Conjunction With a Potassium Ferrate Pad Following Transfemoral Catheterization
NCT number | NCT05468957 |
Other study ID # | 22-000700 |
Secondary ID | |
Status | Recruiting |
Phase | N/A |
First received | |
Last updated | |
Start date | August 1, 2022 |
Est. completion date | July 2024 |
The purpose of this clinical study is to compare how well two different devices for achieving hemostasis perform in patients undergoing transfemoral procedures with 6 French Access. Both devices are approved by the FDA for this use, and have already been used by clinicians on patients undergoing transfemoral procedures. It is believed that the use of both devices in combination compared to the Perclose alone will shorten the time that it takes to 'seal' the artery, resulting in a shorter period of time that patients would need to lay flat.
Status | Recruiting |
Enrollment | 150 |
Est. completion date | July 2024 |
Est. primary completion date | June 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - Patient undergoing diagnostic angiography or PCI with femoral access who undergo PercloseTM closure. - Catheterization with a 6Fr system - Those with a planned radial approach will also be enrolled given the possibility of changing to femoral access in the catheterization lab if radial access is not possible given radial artery spasm, significant patient discomfort with a contraindication to greater levels of sedation, inability to transverse guidewire into the aortic root, inability to engage coronary artery or deliver equipment, or other clinically indicated reason. Exclusion Criteria: - Candidates for this study will be excluded if any one of the following criteria is true: - Use of a hemostasis method or device besides PercloseTM (Perclose may not be used in situations of heavy calcification, presence of dissection, etc). - Patients undergoing catheterization only from the radial, brachial, ulnar, or distal radial (snuffbox) artery approach. - Use of an anticoagulant other than unfractionated heparin or bivalirudin. - Any use of glycoprotein inhibitors or cangrelor. - Use of sheathless guides. - Any anticipated need for continued anticoagulation post-catheterization, including extended bivalirudin infusion. - Any active treatment with oral anticoagulants continued during course of procedure. - Presence of arteriovenous dialysis fistula in the ipsilateral leg. - Any physical deformity or trauma / injury of the leg that would prevent proper placement or function of the hemostasis band. - Inability of the patient to personally consent for the study. (no surrogate consent) - Cardiogenic shock, emergent procedures (high risk myocardial infarctions), or any clinical instability as assessed by the physician performing the procedure. |
Country | Name | City | State |
---|---|---|---|
United States | UCLA Ronald Reagen | Los Angeles | California |
United States | UCLA Santa Monica | Los Angeles | California |
Lead Sponsor | Collaborator |
---|---|
University of California, Los Angeles |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Time to Ambulation | From the time of manual compression after PercloseTM deployed until ambulation is initated after hemostasis is achieved. | Within 30 minutes of discharge or 24 hours post procedure (± 1 hour), whichever occurs first. | |
Secondary | Time to Discharge | From the time of manual compression after PercloseTM deployed until discharge order is activated. | At least 15 minutes after abultation occurs for those in the outpatient setting. | |
Secondary | Time to hemostasis | From the time of manual compression after PercloseTM deployed until hemostasis is achieved without complication. | Within 30 minutes of discharge or 24 hours post procedure (± 1 hour), whichever occurs first | |
Secondary | Percent of patients with hematoma | Presence of small <5cm, medium 5-10cm, or large >10cm hematoma based on physical exam or diagnostic imaging. | Within 30 minutes of discharge or 24 hours post procedure (± 1 hour), whichever occurs first |
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT05650307 -
CV Imaging of Metabolic Interventions
|
||
Recruiting |
NCT05654272 -
Development of CIRC Technologies
|
||
Recruiting |
NCT04515303 -
Digital Intervention Participation in DASH
|
||
Completed |
NCT04056208 -
Pistachios Blood Sugar Control, Heart and Gut Health
|
Phase 2 | |
Recruiting |
NCT04417387 -
The Genetics and Vascular Health Check Study (GENVASC) Aims to Help Determine Whether Gathering Genetic Information Can Improve the Prediction of Risk of Coronary Artery Disease (CAD)
|
||
Not yet recruiting |
NCT06211361 -
Cardiac Rehabilitation Program in Patients With Cardiovascular Disease
|
N/A | |
Not yet recruiting |
NCT06032572 -
Evaluation of the Safety and Effectiveness of the VRS100 System in PCI (ESSENCE)
|
N/A | |
Recruiting |
NCT04514445 -
The BRAVE Study- The Identification of Genetic Variants Associated With Bicuspid Aortic Valve Using a Combination of Case-control and Family-based Approaches.
|
||
Enrolling by invitation |
NCT04253054 -
Chinese Multi-provincial Cohort Study-Beijing Project
|
||
Completed |
NCT03273972 -
INvestigating the Lowest Threshold of Vascular bENefits From LDL Lowering With a PCSK9 InhibiTor in healthY Volunteers
|
N/A | |
Completed |
NCT03680638 -
The Effect of Antioxidants on Skin Blood Flow During Local Heating
|
Phase 1 | |
Recruiting |
NCT04843891 -
Evaluation of PET Probe [64]Cu-Macrin in Cardiovascular Disease, Cancer and Sarcoidosis.
|
Phase 1 | |
Completed |
NCT04083846 -
Clinical Study to Investigate the Pharmacokinetic Profiles and Safety of High-dose CKD-385 in Healthy Volunteers(Fed)
|
Phase 1 | |
Completed |
NCT04083872 -
Clinical Study to Investigate the Pharmacokinetic Profiles and Safety of Highdose CKD-385 in Healthy Volunteers(Fasting)
|
Phase 1 | |
Completed |
NCT03466333 -
Postnatal Enalapril to Improve Cardiovascular fUnction Following Preterm Pre-eclampsia
|
Phase 2 | |
Completed |
NCT03619148 -
The Incidence of Respiratory Symptoms Associated With the Use of HFNO
|
N/A | |
Completed |
NCT03693365 -
Fluid Responsiveness Tested by the Effective Pulmonary Blood Flow During a Positive End-expiratory Trial
|
||
Completed |
NCT04082585 -
Total Health Improvement Program Research Project
|
||
Completed |
NCT05132998 -
Impact of a Comprehensive Cardiac Rehabilitation Program Framework Among High Cardiovascular Risk Cancer Survivors
|
N/A | |
Completed |
NCT05067114 -
Solutions for Atrial Fibrillation Edvocacy (SAFE)
|