Saphenous Vein Graft DiseaseNCT01042444
Use of the GARDEX™ Embolic Protection Device During Percutaneous Coronary Interventions of Saphenous Vein Graft
A study testing GARDEX™ in people with Saphenous Vein Graft Disease and Myocardial Ischemia, run by Gardia Medical at 3 sites in Israel.
Trial summary
This is a multi center, prospective study designed to demonstrate the safety and performance of the GARDEX Embolic Protection System when used as an adjunctive device during saphenous vein graft (SVG) interventions. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Saphenous Vein Graft Disease, Myocardial Ischemia, Embolism
- What is being tested?
- GARDEX™
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 3 sitesIsrael
- Study dates
- Dec 2009to Jan 2011
- Phase
- Interventional
- 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 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Anticipated patient life expectancy of at least 1 year from enrollment.
- Patient (or their legal guardian) has provided a signed informed consent.
- Patient is willing to comply with the protocol requirements.
- Candidate for PCI, stenting and CABG.
- Total CK verified to be within hospital normal limits at the time of enrollment.
- Myocardial ischemia as evidenced by one or more of the following:
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- Diagnosis at time of enrollment of stable or unstable angina pectoris
- Reversible 12 lead ECG changes consisted with ischemia
- Positive function study (e.g. stress test)
- Recent myocardial infarction (>24 hours prior to enrollment with total CK verified to be within hospital normal limits at the time of enrollment).
- Lesions amendable to PCI.
- Lesion(s) is located within SVG and has ≥50% and <100% stenosis (angiographic visual assessment).
- Only single SVG graft to be treated.
- Vessel has thrombolysis in myocardial infarction (TIMI) grade 1 or higher flow before the passage of a guidewire.
- Reference vessel diameter where the GARDEX™ system is to be placed is ≥ 3.5mm and ≤6.0mm in diameter by angiographic visual estimation.
Who cannot join
- A hypersensitivity or contraindication to heparin and bivalirum (Angiomax), aspirin, ticlopidine, clopidogrel, murine products, procedure equipment material, and a sensitivity to contrast dye which cannot be adequately pre-treated with diphenhydramine and/or steroids.
- Myocardial infarction with documented total CK> 2 times the upper limit of normal within the past 24 hours, or currently experiencing an acute myocardial infarction.
- A stroke or transient ischemic attach (TIA) within the past 2 months.
- A history of bleeding diathesis or coagulopathy.
- Major gastrointestinal (GI) bleeding within 3 months of index procedure.
- Baseline creatinine ≥ 2.5 mg/dl.
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- A planned invasive surgical procedure within 30 days.
- Undergone cardiac surgery within the past 60 days.
- The lesion is in a SVG that is less than 2 months post implant.
- Left ventricular ejection fraction < 20%
- The lesion is an arterial conduit.
- Anatomical exclusions that preclude placement of the GARDEX™ system per the Instruction for Use.
- More than one SVG graft that need to be treated at the index procedure.
- Chronic occlusion of the target lesion/severe calcification.
Trial locations and contacts
3 sites in 1 country.
Israel3 sites
Bnai Zion Medical Center
Haifa, 33394
Rabin Medical Center - Beilinson Campus
Petah Tikva, 49100
Tel-Aviv Sourasky Medical Center, Ichilov Hospital
Tel Aviv, 64239
About this study
Official title: Phase I Study to Demonstrate the Safety and Performance of the GARDEX™ Embolic Protection Device When Used During Percutaneous Coronary Intervention (PCI) of Saphenous Vein Graft
This is a multi center, prospective study designed to demonstrate the safety and performance of the GARDEX Embolic Protection System when used as an adjunctive device during saphenous vein graft (SVG) interventions.
- Conditions
- Saphenous Vein Graft Disease, Myocardial Ischemia, Embolism
- Being tested
- GARDEX™
- Keywords
- Heart disease, Embolic Protection Device, PCI, SVG
- Medical subject headings
- Myocardial Ischemia, Embolism, Heart Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GARDEX™Device
GARDEX is an embolic protection system to contain and remove embolic material (thrombus/debris) during cardiovascular interventions.
The diameter of the vessel at the site of filter basket placement should be between 3.5 mm to 6.0 mm. The GARDEX Embolic Protection System may be used with commercially available 0.014" guide wires.
| Study group | Role | What they receive |
|---|---|---|
| Embolic Protection Device | Experimental | The study will involve up to 20 patients to be enrolled using the GARDEX system during clinically indicated percutaneous intervention of SVG and followed through 30 days post procedure. Patients will be enrolled at up to 3 investigative sites. The study is a prospective multi center registry with sequential enrollment of qualified patients who consent to participate and meet the eligibility criteria. Receives: Device: GARDEX™ |
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary objective of the study is to evaluate the safety and performance of the GARDEX Protection System. The primary end point is the combined rate of major adverse events (MACE) at 30 days.
Measured: 30 days
Secondary outcomes (1)
The secondary study objectives includes Device,Angiographic,Procedural and Clinical Success ,Final TIMI flow grade, Angiographically evident emboli
Measured: Device,Angiographic, Procedural Success ,Final TIMI flow grade, Angiographically evident emboli-Procedural; Clinical Success-30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jan 2010 (estimated)
- Study startDec 2009
- Primary completionJan 2011
- Study completionJan 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Saphenous Vein Graft 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gardia Medical
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Uri Rosenschein, MD, Principal investigator, Bnei Zion Hospital, Haifa Israel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01042444
- Sponsor's protocol ID
- Gardia Medical Ltd.
- Status last verified
- Jan 2018
- First submitted
- 30 Dec 2009
- Last updated
- 3 Jan 2018
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 3 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase I Study to Demonstrate the Safety and Performance of the GARDEX™ Embolic Protection Device When Used During Percutaneous Coronary Intervention (PCI) of Saphenous Vein Graft
- ClinicalTrials.gov ID
- NCT01042444
- Acronym / sponsor ID
- Gardia Medical Ltd.
- Conditions
- Saphenous Vein Graft Disease, Myocardial Ischemia, Embolism
- Keywords
- Heart disease, Embolic Protection Device, PCI, SVG
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 6 participants (actual)
- Lead sponsor
- Gardia MedicalIndustry (pharma, biotech, devices)
- Study start
- Dec 2009
- Primary completion
- Jan 2011 (actual)
- Study completion
- Jan 2011 (actual)
- First posted
- 5 Jan 2010 (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.
This is a multi center, prospective study designed to demonstrate the safety and performance of the GARDEX Embolic Protection System when used as an adjunctive device during saphenous vein graft (SVG) interventions.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Embolic Protection Device | Experimental | Device: GARDEX™The study will involve up to 20 patients to be enrolled using the GARDEX system during clinically indicated percutaneous intervention of SVG and followed through 30 days post procedure. Patients will be enrolled at up to 3 investigative sites. The study is a prospective multi center registry with sequential enrollment of qualified patients who consent to participate and meet the eligibility criteria. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- Anticipated patient life expectancy of at least 1 year from enrollment.
- Patient (or their legal guardian) has provided a signed informed consent.
- Patient is willing to comply with the protocol requirements.
- Candidate for PCI, stenting and CABG.
- Total CK verified to be within hospital normal limits at the time of enrollment.
Key exclusion criteria (14 listed)
- A hypersensitivity or contraindication to heparin and bivalirum (Angiomax), aspirin, ticlopidine, clopidogrel, murine products, procedure equipment material, and a sensitivity to contrast dye which cannot be adequately pre-treated with diphenhydramine and/or steroids.
- Myocardial infarction with documented total CK> 2 times the upper limit of normal within the past 24 hours, or currently experiencing an acute myocardial infarction.
- A stroke or transient ischemic attach (TIA) within the past 2 months.
- A history of bleeding diathesis or coagulopathy.
- Major gastrointestinal (GI) bleeding within 3 months of index procedure.
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 |
|---|---|---|
| GARDEX™GARDEX is an embolic protection system to contain and remove embolic material (thrombus/debris) during cardiovascular interventions. The diameter of the vessel at the site of filter basket placement should be between 3.5 mm to 6.0 mm. The GARDEX Embolic Protection System may be used with commercially available 0.014" guide wires. | Device | Embolic Protection Device |
Primary outcome
The primary objective of the study is to evaluate the safety and performance of the GARDEX Protection System. The primary end point is the combined rate of major adverse events (MACE) at 30 days.
Time frame: 30 days
1 secondary outcome
The secondary study objectives includes Device,Angiographic,Procedural and Clinical Success ,Final TIMI flow grade, Angiographically evident emboli
Time frame: Device,Angiographic, Procedural Success ,Final TIMI flow grade, Angiographically evident emboli-Procedural; Clinical Success-30 days
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jan 2018.
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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.
Uri Rosenschein, MD principal investigator
Bnei Zion Hospital, Haifa Israel
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing GARDEX™ in people with Saphenous Vein Graft Disease and Myocardial Ischemia, run by Gardia Medical at 3 sites in Israel.
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 15 inclusion and 14 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: stopped early, as of the sponsor's last update on 3 Jan 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Israel. 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?
The study was stopped early. Results are not available in the source record.
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 objective of the study is to evaluate the safety and performance of the GARDEX Protection System. The primary end point is the combined rate of major adverse events (MACE) at 30 days. (time frame: 30 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 3 Jan 2018.