Cardiac Disease, Coronary Artery Disease
Conditions
Keywords
Hemostasis., Percutaneous coronary interventions., Closure Device
Brief summary
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.
Interventions
DEVICECELT ACD
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.
Sponsors
Vasorum Ltd
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Over 18 years of age. 2. Each patient, or his or her guardian or legal representative, is willing to give informed consent. 3. Clinically indicated for an intra-arterial procedure involving access through the common femoral artery and conducted through an access sheath size of between 6F and 7F inclusive.
Exclusion criteria
1. Patients with known allergy to any of the materials used in the device. 2. Severe acute non-cardiac systemic disease or terminal illness with a life expectancy of less than one year. 3. Evidence of systemic bacterial or cutaneous infection, including groin infection. 4. Patients suffering with definitive or potential coagulopathy or platelet count \<100,000./µl 5. 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. 6. Patients in whom an introducer sheath smaller than 6F or greater than 7F have been used. 7. Currently participating in another investigational device or drug study. 8. 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. 9. If puncture site is via a vascular graft. 10. If a palpable haematoma is observed during the procedure. 11. 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. 12. Patients with a common femoral artery lumen diameter of less than 5 mm. 13. Patients that have any amputation from an access site limb. 14. 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. 15. Patients with a systolic blood pressure reading below 90 mmHg. 16. Patients with an active haematoma, arteriovenous fistula, or pseudoaneurysm. 17. Patients with a very superficial artery where the depth from skin to the artery surface at the access site is less than 4 mm. 18. Morbidly obese patients (Body Mass Index \>35kg/m2). 19. Patients with a stent less than or equal to 1 cm of the puncture site that would interfere with placement of the device implant. 20. Patient is know or suspected to be pregnant, or is lactating. 21. Patients in whom there has been an antegrade puncture. 22. Patients in whom there has been difficulty in obtaining vascular access resulting in multiple arterial punctures and/or posterior arterial wall puncture. 23. Patients who have undergone prior or recent use of an intra-aortic balloon pump through the arterial access site. 24. Patients with uncontrolled hypertension (BP greater than or equal to 180/110mmHg) at time of vascular closure 25. Patients with acute ST-elevation myocardial infarction less than or equal to 48hours before catheterization procedure. 26. Patients with cardiogenic shock (hemodynamic instability requiring intravenous medication or mechanical support) experienced during or immediately post-catheterization. 27. Patients who are unable to ambulate at baseline. 28. Patients known to require an extended hospitalization (e.g. patient is undergoing cardiac surgery). 29. Patient has already participated in the trial. 30. Patient is unavailable for follow up. \-
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The Primary Safety Endpoint Will be the Combined Rate of Major Complications With in 30 +/- 7 Days Following the Percutaneous Coronary Intervention (PCI) Procedure. | With in the first 30 days +/- 7 days following the procedure | rate of major complications with in 30 +/- 7 days following the PCI procedure. |
| The Primary Effectiveness Endpoint Will be Time to Hemostasis (TTH) | With in the first 30 days +/- 7 days following the procedure | Time to hemostasis |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Time to Discharge-ability | 30 days +/- 7 days | Time to discharge-ability |
| The Secondary Safety Endpoint Will be the Combined Rate of Minor Complications With in 30 +/- 7 Days Following Procedure. | With in the first 30 days +/- 7 days following the procedure | combined rate of minor complications with in 30 +/- 7 days following procedure. |
| Device Success | 30 days +/- 7 days | 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. |
| Procedure Success | 30 days +/- 7 days | Procedure Success 30 days +/- 7 days |
| Time to Ambulation | With in the first 30 days +/- 7 days following the procedure | 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. |
Countries
Germany, Ireland, United States
Participant flow
Pre-assignment details
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.
Participants by arm
| Arm | Count |
|---|---|
| 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. | 148 |
| Manual Compression Manual Compression | 59 |
| Total | 207 |
Baseline characteristics
| Characteristic | Manual Compression | Total | CELT ACD Device |
|---|---|---|---|
| Age, Continuous | 67.44 Years STANDARD_DEVIATION 11.7 | 66.95 Years STANDARD_DEVIATION 11 | 66.75 Years STANDARD_DEVIATION 10.8 |
| BMI | 28.18 kg/m^2 STANDARD_DEVIATION 4.41 | 27.87 kg/m^2 STANDARD_DEVIATION 4.45 | 27.75 kg/m^2 STANDARD_DEVIATION 4.47 |
| Height | 171.70 cm STANDARD_DEVIATION 7.82 | 172.50 cm STANDARD_DEVIATION 9.12 | 172.90 cm STANDARD_DEVIATION 9.56 |
| Race and Ethnicity Not Collected | — | 0 Participants | — |
| Region of Enrollment Germany | 18 participants | 60 participants | 42 participants |
| Region of Enrollment Ireland | 21 participants | 90 participants | 69 participants |
| Region of Enrollment United States | 20 participants | 57 participants | 37 participants |
| Right Femoral Artery Site | 57 Participants | 199 Participants | 142 Participants |
| Sex: Female, Male Female | 12 Participants | 48 Participants | 36 Participants |
| Sex: Female, Male Male | 47 Participants | 159 Participants | 112 Participants |
| Weight | 82.78 Kgs STANDARD_DEVIATION 40.83 | 84.65 Kgs STANDARD_DEVIATION 15.8 | 85.38 Kgs STANDARD_DEVIATION 16.22 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 148 | 0 / 59 |
| other Total, other adverse events | 0 / 148 | 0 / 59 |
| serious Total, serious adverse events | 1 / 148 | 2 / 59 |
Outcome results
Primary
The Primary Effectiveness Endpoint Will be Time to Hemostasis (TTH)
Time to hemostasis
Time frame: With in the first 30 days +/- 7 days following the procedure
Population: 7 subjects in manual compression group where TTH was not recorded.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| CELT ACD Device | The Primary Effectiveness Endpoint Will be Time to Hemostasis (TTH) | 0.99 minutes | Standard Deviation 4.15 |
| Manual Compression | The Primary Effectiveness Endpoint Will be Time to Hemostasis (TTH) | 17.54 minutes | Standard Deviation 54.55 |
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.
Time frame: With in the first 30 days +/- 7 days following the procedure
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| CELT ACD Device | The Primary Safety Endpoint Will be the Combined Rate of Major Complications With in 30 +/- 7 Days Following the Percutaneous Coronary Intervention (PCI) Procedure. | 1 major complications |
| Manual Compression | The Primary Safety Endpoint Will be the Combined Rate of Major Complications With in 30 +/- 7 Days Following the Percutaneous Coronary Intervention (PCI) Procedure. | 2 major complications |
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.
Time frame: 30 days +/- 7 days
Population: 7 patients in the MP group did not have TTH recorded.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| CELT ACD Device | Device Success | 147 Number of patients |
Secondary
Procedure Success
Procedure Success 30 days +/- 7 days
Time frame: 30 days +/- 7 days
Population: 7 patients were excluded in Manual Compression group as there was no TTH data recorded.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| CELT ACD Device | Procedure Success | 147 Number of patients |
| Manual Compression | Procedure Success | 51 Number of patients |
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.
Time frame: With in the first 30 days +/- 7 days following the procedure
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| CELT ACD Device | The Secondary Safety Endpoint Will be the Combined Rate of Minor Complications With in 30 +/- 7 Days Following Procedure. | 7 minor complications |
| Manual Compression | The Secondary Safety Endpoint Will be the Combined Rate of Minor Complications With in 30 +/- 7 Days Following Procedure. | 5 minor complications |
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.
Time frame: With in the first 30 days +/- 7 days following the procedure
Population: 62 patients did not have TTA recorded.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| CELT ACD Device | Time to Ambulation | 360.0 minutes | Standard Deviation 418.4 |
| Manual Compression | Time to Ambulation | 406.4 minutes | Standard Deviation 216.2 |
Secondary
Time to Discharge-ability
Time to discharge-ability
Time frame: 30 days +/- 7 days
Population: 107 did not have time to dischargeability data collected.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| CELT ACD Device | Time to Discharge-ability | 662.51 Minutes | Standard Deviation 511.7 |
| Manual Compression | Time to Discharge-ability | 511.76 Minutes | Standard Deviation 350.2 |