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The objective of the CELT ACD® Vascular Closure Device study is to evaluate the safety and effectiveness of the CELT ACD® device to achieve hemostasis of the common femoral artery access site in patients on anticoagulation who are undergoing a percutaneous intervention (PCI) procedure using a 6F sheath.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CELT ACD device | Experimental | The CELT ACD device is a vascular closure device. |
|
| Manual Compression | No Intervention | Manual Compression |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CELT ACD | Device | The CELT ACD will be used to achieve hemostasis of the common femoral artery in patients on anticoagulation who are undergoing a percutaneous intervention procedure using a 6F procedural sheath. |
| Measure | Description | Time Frame |
|---|---|---|
| The Primary Safety Endpoint Will be the Combined Rate of Major Complications With in 30 +/- 7 Days Following the Percutaneous Coronary Intervention (PCI) Procedure. | rate of major complications with in 30 +/- 7 days following the PCI procedure. | With in the first 30 days +/- 7 days following the procedure |
| The Primary Effectiveness Endpoint Will be Time to Hemostasis (TTH) | Time to hemostasis | With in the first 30 days +/- 7 days following the procedure |
| Measure | Description | Time Frame |
|---|---|---|
| The Secondary Safety Endpoint Will be the Combined Rate of Minor Complications With in 30 +/- 7 Days Following Procedure. | combined rate of minor complications with in 30 +/- 7 days following procedure. | With in the first 30 days +/- 7 days following the procedure |
| Time to Ambulation |
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Inclusion Criteria:
Exclusion Criteria:
Patients with known allergy to any of the materials used in the device.
Severe acute non-cardiac systemic disease or terminal illness with a life expectancy of less than one year.
Evidence of systemic bacterial or cutaneous infection, including groin infection.
Patients suffering with definitive or potential coagulopathy or platelet count <100,000./µl
Use of systemic thrombolytic agents within 24 hours prior to or during the catheterization procedure which cause the concentration of fibrinogen to be < 100 mg/dl or if post-thrombolytic fibrinogen (in case of thrombolysis within 24 hours or intra-procedural) cannot be measured.
Patients in whom an introducer sheath smaller than 6F or greater than 7F have been used.
Currently participating in another investigational device or drug study.
Patients with severe claudication, iliac or femoral artery diameter stenosis greater than 50%, or previous bypass surgery or stent placement in the vicinity of the access site.
If puncture site is via a vascular graft.
If a palpable haematoma is observed during the procedure.
Patients in whom there is any indication that puncture has been made in the profunda femorals artery or superficial femoral artery, or adjacent to the bifurcation.
Patients with a common femoral artery lumen diameter of less than 5 mm.
Patients that have any amputation from an access site limb.
Patients that have undergone a percutaneous procedure using a vascular closure device for hemostasis within the previous 30 days or using manual/mechanical pressure for hemostasis within the prior 30 days in the same leg.
Patients with a systolic blood pressure reading below 90 mmHg.
Patients with an active haematoma, arteriovenous fistula, or pseudoaneurysm.
Patients with a very superficial artery where the depth from skin to the artery surface at the access site is less than 4 mm.
Morbidly obese patients (Body Mass Index >35kg/m2).
Patients with a stent less than or equal to 1 cm of the puncture site that would interfere with placement of the device implant.
Patient is know or suspected to be pregnant, or is lactating.
Patients in whom there has been an antegrade puncture.
Patients in whom there has been difficulty in obtaining vascular access resulting in multiple arterial punctures and/or posterior arterial wall puncture.
Patients who have undergone prior or recent use of an intra-aortic balloon pump through the arterial access site.
Patients with uncontrolled hypertension (BP greater than or equal to 180/110mmHg) at time of vascular closure
Patients with acute ST-elevation myocardial infarction less than or equal to 48hours before catheterization procedure.
Patients with cardiogenic shock (hemodynamic instability requiring intravenous medication or mechanical support) experienced during or immediately post-catheterization.
Patients who are unable to ambulate at baseline.
Patients known to require an extended hospitalization (e.g. patient is undergoing cardiac surgery).
Patient has already participated in the trial.
Patient is unavailable for follow up.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cooper University Hospital | Camden | New Jersey | 08103 | United States | ||
| New York Presbyterian Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28296003 | Derived | Wong SC, Laule M, Turi Z, Sanad W, Crowley J, Degen H, Bennett K, Coleman JE, Bergman G. A multicenter randomized trial comparing the effectiveness and safety of a novel vascular closure device to manual compression in anticoagulated patients undergoing percutaneous transfemoral procedures: The CELT ACD trial. Catheter Cardiovasc Interv. 2017 Nov 1;90(5):756-765. doi: 10.1002/ccd.26991. Epub 2017 Mar 15. |
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As per agreement with FDA, following the 207 patient 6F Celt ACD study, an additional 34 patients were recruited across 3 clinical investigation sites whereby a 7F Celt ACD device was used to close an arterial puncture made with a 7F sheath in fully anti-coagulated patients. 7F device approval is pending with FDA.
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| ID | Title | Description |
|---|---|---|
| FG000 | CELT ACD Device | The CELT ACD device is a vascular closure device. CELT ACD: The CELT ACD will be used to achieve hemostasis of the common femoral artery in patients on anticoagulation who are undergoing a percutaneous coronary intervention procedure using either a 6F or a 7F procedural sheath. |
| FG001 | Manual Compression | Manual Compression |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | CELT ACD Device | The CELT ACD device is a vascular closure device. CELT ACD: The CELT ACD will be used to achieve hemostasis of the common femoral artery in patients on anticoagulation who are undergoing a percutaneous coronary intervention procedure using either a 6F or a 7F procedural sheath. |
| BG001 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | The Primary Safety Endpoint Will be the Combined Rate of Major Complications With in 30 +/- 7 Days Following the Percutaneous Coronary Intervention (PCI) Procedure. | rate of major complications with in 30 +/- 7 days following the PCI procedure. | Posted | Number | major complications | With in the first 30 days +/- 7 days following the procedure |
|
30 days +/- 7 days
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | CELT ACD Device | The CELT ACD device is a vascular closure device. CELT ACD: The CELT ACD will be used to achieve hemostasis of the common femoral artery in patients on anticoagulation who are undergoing a percutaneous coronary intervention procedure using either a 6F or a 7F procedural sheath. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Device migration | Surgical and medical procedures | Device migration from femoral artery access point |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr James Coleman | Vasorum Ltd | 00 353 1 4035460 | jcoleman@vasorum.ie |
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| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D003324 | Coronary Artery Disease |
| ID | Term |
|---|---|
| D002318 | Cardiovascular Diseases |
| D003327 | Coronary Disease |
| D017202 | Myocardial Ischemia |
| D001161 | Arteriosclerosis |
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Time to Ambulation (TTA) is defined as the time elapsed between sheath removal and time when the patient stands and walk 6m (20ft) without re-bleeding. |
| With in the first 30 days +/- 7 days following the procedure |
| Time to Discharge-ability | Time to discharge-ability | 30 days +/- 7 days |
| Procedure Success | Procedure Success 30 days +/- 7 days | 30 days +/- 7 days |
| Device Success | Device Success (DS) is defined as the successful deployment of the Celt ACD device with the attainment of haemostasis and only assessed in the Celt ACD arm of the study. | 30 days +/- 7 days |
| New York |
| New York |
| 10021 |
| United States |
| Städtische Kliniken Neuss - Lukaskrankenhaus - GmbH | Preußenstr. 84,41464 Neuss | Neuss | 41464 Neuss | Germany |
| Charite Campus Mitte | Berlin | 10117 | Germany |
| Galway University Hosptial | Galway | Ireland | Ireland |
| Manual Compression |
Manual Compression |
| BG002 | Total | Total of all reporting groups |
| Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Weight | Mean | Standard Deviation | Kgs |
|
| Height | Mean | Standard Deviation | cm |
|
| BMI | Mean | Standard Deviation | kg/m^2 |
|
| Right Femoral Artery Site | Count of Participants | Participants |
|
|
|
| Primary | The Primary Effectiveness Endpoint Will be Time to Hemostasis (TTH) | Time to hemostasis | 7 subjects in manual compression group where TTH was not recorded. | Posted | Mean | Standard Deviation | minutes | With in the first 30 days +/- 7 days following the procedure |
|
|
|
| Secondary | The Secondary Safety Endpoint Will be the Combined Rate of Minor Complications With in 30 +/- 7 Days Following Procedure. | combined rate of minor complications with in 30 +/- 7 days following procedure. | Posted | Number | minor complications | With in the first 30 days +/- 7 days following the procedure |
|
|
|
| Secondary | Time to Ambulation | Time to Ambulation (TTA) is defined as the time elapsed between sheath removal and time when the patient stands and walk 6m (20ft) without re-bleeding. | 62 patients did not have TTA recorded. | Posted | Mean | Standard Deviation | minutes | With in the first 30 days +/- 7 days following the procedure |
|
|
|
| Secondary | Time to Discharge-ability | Time to discharge-ability | 107 did not have time to dischargeability data collected. | Posted | Mean | Standard Deviation | Minutes | 30 days +/- 7 days |
|
|
|
| Secondary | Procedure Success | Procedure Success 30 days +/- 7 days | 7 patients were excluded in Manual Compression group as there was no TTH data recorded. | Posted | Number | Number of patients | 30 days +/- 7 days |
|
|
|
| Secondary | Device Success | Device Success (DS) is defined as the successful deployment of the Celt ACD device with the attainment of haemostasis and only assessed in the Celt ACD arm of the study. | 7 patients in the MP group did not have TTH recorded. | Posted | Number | Number of patients | 30 days +/- 7 days |
|
|
|
| 0 |
| 148 |
| 1 |
| 148 |
| 0 |
| 148 |
| EG001 | Manual Compression | Manual Compression | 0 | 59 | 2 | 59 | 0 | 59 |
| Syncope | Surgical and medical procedures | Syncope during the follow up period |
|
| Brain Stem Ischemia | Vascular disorders | Brain stem ischemia unrelated to procedure |
|
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| D001157 |
| Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |