Cardiac DiseaseNCT01600482
Clinical Investigation for Safety and Efficacy Study of CELT ACD (Arterial ClosureDevice)
A study testing CELT ACD in people with Cardiac Disease and Coronary Artery Disease, run by Vasorum Ltd at 5 sites in 3 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cardiac Disease, Coronary Artery Disease
- What is being tested?
- CELT ACD
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 241 participants
- Where
- 5 sitesin 3 countries
- Study dates
- May 2012to Feb 2016
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 31Show fewer
- 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.
- -
Trial locations and contacts
5 sites in 3 countries.
5 sites in 3 countries
United States2 sites
Cooper University Hospital
Camden, New Jersey, 08103
New York Presbyterian Hospital
New York, New York, 10021
Germany2 sites
Charite Campus Mitte
Berlin, 10117
Städtische Kliniken Neuss - Lukaskrankenhaus - GmbH
Preußenstr. 84,41464 Neuss, Neuss, 41464 Neuss
About this study
Official title: Clinical Investigation Plan (CIP) for Safety and Efficacy Study of Arterial Closure Device (CELT ACD). Clinical Investigation Plan No.: CIP-TS-003
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.
- Conditions
- Cardiac Disease, Coronary Artery Disease
- Being tested
- CELT ACD
- Keywords
- Hemostasis., Percutaneous coronary interventions., Closure Device
- Medical subject headings
- Heart Diseases, Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CELT ACDDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| CELT ACD device | Experimental | The CELT ACD device is a vascular closure device. Receives: Device: CELT ACD |
| Manual Compression | No intervention | Manual Compression |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: With in the first 30 days +/- 7 days following the procedure
The Primary Effectiveness Endpoint Will be Time to Hemostasis (TTH)
Time to hemostasis
Measured: With in the first 30 days +/- 7 days following the procedure
Secondary outcomes (5)
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.
Measured: With in the first 30 days +/- 7 days following the procedure
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.
Measured: With in the first 30 days +/- 7 days following the procedure
Time to Discharge-ability
Time to discharge-ability
Measured: 30 days +/- 7 days
Procedure Success
Procedure Success 30 days +/- 7 days
Measured: 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.
Measured: 30 days +/- 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 May 2012 (estimated)
- Study startMay 2012
- Primary completionFeb 2016
- Study completionFeb 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cardiac DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 241 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vasorum Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01600482
- Sponsor's protocol ID
- CIP-TS-003
- Status last verified
- Jul 2017
- First submitted
- 16 May 2012
- Last updated
- 23 Aug 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
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.
PubMed 28296003
Study at a glance
From the registry record, last updated by the sponsor on 23 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Investigation Plan (CIP) for Safety and Efficacy Study of Arterial Closure Device (CELT ACD). Clinical Investigation Plan No.: CIP-TS-003
- ClinicalTrials.gov ID
- NCT01600482
- Acronym / sponsor ID
- CIP-TS-003
- Conditions
- Cardiac Disease, Coronary Artery Disease
- Keywords
- Hemostasis., Percutaneous coronary interventions., Closure Device
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 241 participants (actual)
- Lead sponsor
- Vasorum LtdIndustry (pharma, biotech, devices)
- Study start
- May 2012
- Primary completion
- Feb 2016 (actual)
- Study completion
- Feb 2016 (actual)
- First posted
- 17 May 2012 (estimated)
- Results
- Posted 23 Aug 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CELT ACD device | Experimental | Device: CELT ACDThe CELT ACD device is a vascular closure device. |
| Manual Compression | No intervention | –Manual Compression |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (31 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CELT ACDThe 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. | Device | CELT ACD device |
Primary outcome
The Primary Safety Endpoint Will be the Combined Rate of Major Complications With in 30 +/- 7 Days Following the Percutaneous Coronary Intervention (PCI) Procedure.
Time frame: 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)
Time frame: With in the first 30 days +/- 7 days following the procedure
Time to hemostasis
5 secondary outcomes
The Secondary Safety Endpoint Will be the 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
Time to Ambulation
Time frame: With in the first 30 days +/- 7 days following the procedure
Time to Discharge-ability
Time frame: 30 days +/- 7 days
Procedure Success
Time frame: 30 days +/- 7 days
Device Success
Time frame: 30 days +/- 7 days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Aug 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 28296003Wong 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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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
5 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CELT ACD in people with Cardiac Disease and Coronary Artery Disease, run by Vasorum Ltd at 5 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 31 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Aug 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in United States, Germany, Ireland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 23 Aug 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The Primary Safety Endpoint Will be the Combined Rate of Major Complications With in 30 +/- 7 Days Following the Percutaneous Coronary Intervention (PCI) Procedure. (time frame: With in the first 30 days +/- 7 days following the procedure). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01600482, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Aug 2017.