N/A
N=207
Clinical Investigation for Safety and Efficacy Study of CELT ACD (Arterial ClosureDevice)
Cardiac Disease · Coronary Artery Disease
Bottom Line
View on ClinicalTrials.gov: NCT01600482 ↗Enrolled (actual)
207
Serious AEs
1.5%
Results posted
Aug 2017
Primary outcome: 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. — 1; 2 major complications
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- CELT ACD (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Vasorum Ltd
- Primary completion
- Feb 2016
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| 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. |
1; 2 | — |
| PRIMARY The Primary Effectiveness Endpoint Will be Time to Hemostasis (TTH) |
0.99; 17.54 | — |
| SECONDARY The Secondary Safety Endpoint Will be the Combined Rate of Minor Complications With in 30 +/- 7 Days Following Procedure. |
7; 5 | — |
| SECONDARY Time to Ambulation |
360.0; 406.4 | — |
| SECONDARY Time to Discharge-ability |
662.51; 511.76 | — |
| SECONDARY Procedure Success |
147; 51 | — |
| SECONDARY Device Success |
147 | — |
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.
Eligibility Criteria
Inclusion Criteria
- Over 18 years of age.
- Each patient, or his or her guardian or legal representative, is willing to give informed consent.
- 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
- 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 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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Data sourced from ClinicalTrials.gov (NCT01600482). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.