Angioplasty, Transluminal, Percutaneous CoronaryPhase 1ECLIPSENCT00574691
ECLIPSE Feasibility Trial (Ensure's Vascular Closure Device Speeds Hemostasis Trial) EU
A Phase 1 study testing 7F Ensure Medical Vascular Closure Device in people with Angioplasty, Transluminal, Percutaneous Coronary and Coronary Arteriosclerosis, run by Cordis US Corp. at 1 site in Germany.
Trial summary
To assess the safety and feasibility of the 7F Ensure Medical Vascular Closure Devices to facilitate hemostasis in patients undergoing diagnostic or interventional procedures. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Angioplasty, Transluminal, Percutaneous Coronary, Coronary Arteriosclerosis
- What is being tested?
- 7F Ensure Medical Vascular Closure Device
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 93 participants
- Where
- 1 siteGermany
- Study dates
- Jun 2007to Oct 2007
- Phase
- Phase 1
- Are there results?
- None posted in the registry
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 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient is between 18 and 85 years of age
- Patient/legal representative provides written informed consent
- Patient is scheduled for a coronary or peripheral diagnostic or interventional procedure
- Patient is able to undergo emergent vascular surgery if a complication related to the VCD necessitates such surgery
- Patient has a 7F arterial puncture located in the common femoral artery
- Target vessel has a lumen diameter ≥ 5 mm
- Patient is willing and able to complete follow-up
- Catheterization procedure is planned and elective
Who cannot join
- Arterial puncture in the femoral artery of both legs
- Prior target artery closure with any closure device or closure with manual compression ≤ 30 days prior to the cardiac or peripheral catheterization procedure
- Patients with a history of significant bleeding or with any known or documented bleeding disorders, such as Thrombocytopenia (with < 100,000 platelet count), Von Willebrand's disease, anemia (Hgb < 10 g/dL, Hct < 30%), thrombasthenia, decreased fibrinogen (< 200 mg/dL), and Factor V deficiency
- Acute ST-elevation myocardial infarction ≤ 48 hours prior to the cardiac or peripheral catheterization procedure
- Uncontrolled hypertension (BP ≥ 180/110 mmHg)
- Heparinized patients with elevated pre-closure ACT level:> 250 seconds with GP IIb/IIIa inhibitor > 300 seconds no GP IIb/IIIa inhibitor
Show all 33Show fewer
- Patient is ineligible for in-lab catheterization lab introducer sheath removal
- Concurrent participation in another investigational device or drug trial
- Thrombolytic therapy (e.g. streptokinase, urokinase, t-PA) ≤ 24 hours prior to the cardiac or peripheral catheterization procedure
- Angiomax (bivalirudin) or other thrombin-specific anticoagulants or low molecular weight heparin ≤ 24 hours prior to the cardiac or peripheral catheterization procedure
- Evidence of a preexisting hematoma, arteriovenous fistula, or pseudoaneurysm at the access site prior to start of femoral artery closure procedure
- Prior femoral vascular surgery or vascular graft in region of access site or contralateral common femoral artery
- The targeted femoral artery is tortuous or requires an introducer sheath length > 11 cm
- Fluoroscopically visible calcium, atherosclerotic disease, or stent ≤ 1 cm of the puncture site that would interfere with the placement of the VCD's plug
- Difficulty in obtaining vascular access resulting in multiple arterial punctures and/or posterior arterial puncture
- Antegrade puncture
- BMI > 40 kg/m2
- Symptomatic leg ischemia in the target vessel limb including severe claudication (< 50 meter) or weak/absent pulse
- Targeted femoral artery diameter stenosis ≥ 50%
- Pre-existing severe non-cardiac systemic disease or pre-existing terminal illness
- Planned arterial access at the same access site ≤ 30 days following the femoral artery closure procedure
- Patient has known allergy to any materials used in the VCD
- Patient is known to require an extended hospitalization (e.g. patient is undergoing CABG surgery)
- Pre-existing systemic or cutaneous infection
- Prior or recent use of an intra-aortic balloon pump through the arterial access site
- Cardiogenic shock (hemodynamic instability requiring intravenous medications or mechanical support) experienced during or immediately post-catheterization
- Patient is unable to ambulate at baseline
- Patient is known or suspected to be pregnant, or is lactating
- Patient has already participated in this trial
- Patient has known allergy to contrast medium
- Patient is unavailable for follow-up
- Any angiographic or clinical evidence that the investigator feels would place the patient at increased risk with the use of the VCD
- Required simultaneous ipsilateral or contralateral venous puncture
Trial locations and contacts
1 site in 1 country.
About this study
Official title: ECLIPSE Feasibility Trial (Ensure's Vascular Closure Device Speeds Hemostasis) Trial
To assess the safety and feasibility of the 7F Ensure Medical Vascular Closure Devices to facilitate hemostasis in patients undergoing diagnostic or interventional procedures.
Read the detailed description
Multi-center (up to 6 European sites), non-blinded, non-randomized, feasibility study with a 2-month enrollment period and 30-day clinical follow-up.
60 patients (plus up to 36 "roll-in" device training patients) undergoing diagnostic or interventional coronary or peripheral procedures utilizing a 7F arterial puncture in the common femoral artery. Patients are excluded if they have a previous target artery closure with any closure device, recent myocardial infarction or thrombolytic therapy, treatment with thrombin-specific anticoagulants or low molecular weight heparin, fluoroscopically visible calcium or atherosclerosis ≤ 1 cm of puncture site, or planned target site access ≤ 30 days.
- Being tested
- 7F Ensure Medical Vascular Closure Device
- Keywords
- Closure Device, Angiography, Angioplasty, Hemostasis, Heart Catheterization, Coronary Angiography
- Medical subject headings
- Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
7F Ensure Medical Vascular Closure DeviceDevice
Also called Ensure Medical Vascular Closure Device
Vascular Closure Device
| Study group | Role | What they receive |
|---|---|---|
| 1 | Other | Vascular Closure Device Receives: Device: 7F Ensure Medical Vascular Closure Device |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to hemostasis and time to ambulation.
Measured: at time introducer sheath is removed
Combined rate of the following SAEs:Vascular injury or repair; access site bleeding, infection, nerve injury; ipsilateral lower extremity ischemia.
Measured: 30 days
Secondary outcomes (23)
Device success.
Measured: initial hemostasis time ≤ 5 minutes and removal of the intact delivery system
Procedural success.
Measured: 30 days
Time the patient is deemed eligible for hospital discharge.
Measured: time of the access site closure until patient is discharge
Rebleeding following initial hemostasis requiring a subsequent intervention.
Measured: prior to hospital discharge, and at the 30-day follow-up
Pseudoaneurysm not requiring treatment.
Measured: prior to hospital discharge, and at the 30-day follow-up
Pseudoaneurysm treated with ultrasound-guided thrombin injection or ultrasound-guided fibrin adhesive injection.
Measured: prior to hospital discharge, and at the 30-day follow-up
Arteriovenous fistula documented by ultrasound or CT scan.
Measured: prior to hospital discharge, and at the 30-day follow-up
Access site hematoma ≥ 6 cm.
Measured: prior to hospital discharge, and at the 30-day follow-up
Post-hospital discharge access site-related bleeding.
Measured: prior to hospital discharge, and at the 30-day follow-up
Access site-related bleeding requiring > 30 minutes to achieve hemostasis.
Measured: prior to hospital discharge, and at the 30-day follow-up
Ipsilateral lower extremity arterial emboli.
Measured: prior to hospital discharge, and at the 30-day follow-up
Transient loss of ipsilateral lower extremity pulse.
Measured: prior to hospital discharge, and at the 30-day follow-up
Ipsilateral deep vein thrombosis.
Measured: prior to hospital discharge, and at the 30-day follow-up
Access site-related vessel laceration.
Measured: prior to hospital discharge, and at the 30-day follow-up
Transient access site-related nerve injury
Measured: prior to hospital discharge, and at the 30-day follow-up
Access site wound dehiscence.
Measured: prior to hospital discharge, and at the 30-day follow-up
Localized access site infection treated with oral antibiotics.
Measured: prior to hospital discharge, and at the 30-day follow-up
Retroperitoneal bleeding.
Measured: prior to hospital discharge, and at the 30-day follow-up
Ipsilateral peripheral artery total occlusion.
Measured: prior to hospital discharge, and at the 30-day follow-up
Ecchymosis ≥ 6 cm.
Measured: prior to hospital discharge, and at the 30-day follow-up
Intraluminal plug delivery not requiring surgical intervention.
Measured: prior to hospital discharge, and at the 30-day follow-up
Decrease in pedal pulse.
Measured: prior to hospital discharge, and at the 30-day follow-up
Death.
Measured: prior to hospital discharge, and at the 30-day follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Dec 2007 (estimated)
- Study startJun 2007
- Study completionOct 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Angioplasty, Transluminal, Percutaneous CoronaryStudies 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 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 93 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cordis US Corp.
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Marcus Wiemer, Dr., Principal investigator, Herz-und Diabeteszentrum NRW
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00574691
- Sponsor's protocol ID
- EM 06-01EU
- Acronym
- ECLIPSE
- Status last verified
- Feb 2012
- First submitted
- 13 Dec 2007
- Last updated
- 28 Feb 2012
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Wiemer M, Langer C, Fichtlscherer S, Firschke C, Hofbauer F, Lins M, Haude M, Debefve C, Stoll HP, Hanefeld C. First-in-man experience with a new 7F vascular closure device (EXOSEAL): the 7F ECLIPSE study. J Interv Cardiol. 2012 Oct;25(5):518-25. doi: 10.1111/j.1540-8183.2012.00739.x. Epub 2012 Jul 5.
PubMed 22762417
Study at a glance
From the registry record, last updated by the sponsor on 28 Feb 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ECLIPSE Feasibility Trial (Ensure's Vascular Closure Device Speeds Hemostasis) Trial
- ClinicalTrials.gov ID
- NCT00574691
- Acronym / sponsor ID
- ECLIPSE / EM 06-01EU
- Keywords
- Closure Device, Angiography, Angioplasty, Hemostasis, Heart Catheterization, Coronary Angiography
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 93 participants (actual)
- Lead sponsor
- Cordis US Corp.Industry (pharma, biotech, devices)
- Study start
- Jun 2007
- Study completion
- Oct 2007 (actual)
- First posted
- 17 Dec 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To assess the safety and feasibility of the 7F Ensure Medical Vascular Closure Devices to facilitate hemostasis in patients undergoing diagnostic or interventional procedures.
Detailed description
Multi-center (up to 6 European sites), non-blinded, non-randomized, feasibility study with a 2-month enrollment period and 30-day clinical follow-up.
60 patients (plus up to 36 "roll-in" device training patients) undergoing diagnostic or interventional coronary or peripheral procedures utilizing a 7F arterial puncture in the common femoral artery. Patients are excluded if they have a previous target artery closure with any closure device, recent myocardial infarction or thrombolytic therapy, treatment with thrombin-specific anticoagulants or low molecular weight heparin, fluoroscopically visible calcium or atherosclerosis ≤ 1 cm of puncture site, or planned target site access ≤ 30 days.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | Other | Device: 7F Ensure Medical Vascular Closure DeviceVascular Closure Device |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Patient is between 18 and 85 years of age
- Patient/legal representative provides written informed consent
- Patient is scheduled for a coronary or peripheral diagnostic or interventional procedure
- Patient is able to undergo emergent vascular surgery if a complication related to the VCD necessitates such surgery
- Patient has a 7F arterial puncture located in the common femoral artery
Key exclusion criteria (33 listed)
- Arterial puncture in the femoral artery of both legs
- Prior target artery closure with any closure device or closure with manual compression ≤ 30 days prior to the cardiac or peripheral catheterization procedure
- Patients with a history of significant bleeding or with any known or documented bleeding disorders, such as Thrombocytopenia (with < 100,000 platelet count), Von Willebrand's disease, anemia (Hgb < 10 g/dL, Hct < 30%), thrombasthenia, decreased fibrinogen (< 200 mg/dL), and Factor V deficiency
- Acute ST-elevation myocardial infarction ≤ 48 hours prior to the cardiac or peripheral catheterization procedure
- Uncontrolled hypertension (BP ≥ 180/110 mmHg)
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 |
|---|---|---|
| 7F Ensure Medical Vascular Closure DeviceAlso: Ensure Medical Vascular Closure DeviceVascular Closure Device | Device | 1 |
Primary outcome
Time to hemostasis and time to ambulation.
Time frame: at time introducer sheath is removed
Combined rate of the following SAEs:Vascular injury or repair; access site bleeding, infection, nerve injury; ipsilateral lower extremity ischemia.
Time frame: 30 days
23 secondary outcomes
Device success.
Time frame: initial hemostasis time ≤ 5 minutes and removal of the intact delivery system
Procedural success.
Time frame: 30 days
Time the patient is deemed eligible for hospital discharge.
Time frame: time of the access site closure until patient is discharge
Rebleeding following initial hemostasis requiring a subsequent intervention.
Time frame: prior to hospital discharge, and at the 30-day follow-up
Pseudoaneurysm not requiring treatment.
Time frame: prior to hospital discharge, and at the 30-day follow-up
Pseudoaneurysm treated with ultrasound-guided thrombin injection or ultrasound-guided fibrin adhesive injection.
Time frame: prior to hospital discharge, and at the 30-day follow-up
Arteriovenous fistula documented by ultrasound or CT scan.
Time frame: prior to hospital discharge, and at the 30-day follow-up
Access site hematoma ≥ 6 cm.
Time frame: prior to hospital discharge, and at the 30-day follow-up
Post-hospital discharge access site-related bleeding.
Time frame: prior to hospital discharge, and at the 30-day follow-up
Access site-related bleeding requiring > 30 minutes to achieve hemostasis.
Time frame: prior to hospital discharge, and at the 30-day follow-up
Ipsilateral lower extremity arterial emboli.
Time frame: prior to hospital discharge, and at the 30-day follow-up
Transient loss of ipsilateral lower extremity pulse.
Time frame: prior to hospital discharge, and at the 30-day follow-up
Ipsilateral deep vein thrombosis.
Time frame: prior to hospital discharge, and at the 30-day follow-up
Access site-related vessel laceration.
Time frame: prior to hospital discharge, and at the 30-day follow-up
Transient access site-related nerve injury
Time frame: prior to hospital discharge, and at the 30-day follow-up
Access site wound dehiscence.
Time frame: prior to hospital discharge, and at the 30-day follow-up
Localized access site infection treated with oral antibiotics.
Time frame: prior to hospital discharge, and at the 30-day follow-up
Retroperitoneal bleeding.
Time frame: prior to hospital discharge, and at the 30-day follow-up
Ipsilateral peripheral artery total occlusion.
Time frame: prior to hospital discharge, and at the 30-day follow-up
Ecchymosis ≥ 6 cm.
Time frame: prior to hospital discharge, and at the 30-day follow-up
Intraluminal plug delivery not requiring surgical intervention.
Time frame: prior to hospital discharge, and at the 30-day follow-up
Decrease in pedal pulse.
Time frame: prior to hospital discharge, and at the 30-day follow-up
Death.
Time frame: prior to hospital discharge, and at the 30-day follow-up
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Feb 2012.
- Derived from this study: PubMed 22762417Wiemer M, Langer C, Fichtlscherer S, Firschke C, Hofbauer F, Lins M, Haude M, Debefve C, Stoll HP, Hanefeld C. First-in-man experience with a new 7F vascular closure device (EXOSEAL): the 7F ECLIPSE study. J Interv Cardiol. 2012 Oct;25(5):518-25. doi: 10.1111/j.1540-8183.2012.00739.x. Epub 2012 Jul 5.
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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.
Marcus Wiemer, Dr. principal investigator
Herz-und Diabeteszentrum NRW
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing 7F Ensure Medical Vascular Closure Device in people with Angioplasty, Transluminal, Percutaneous Coronary and Coronary Arteriosclerosis, run by Cordis US Corp. at 1 site in Germany.
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 8 inclusion and 33 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 28 Feb 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. 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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Time to hemostasis and time to ambulation. (time frame: at time introducer sheath is removed). 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 NCT00574691, 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 28 Feb 2012.