Coronary Artery DiseaseNCT02543047
The Angioshield Study Feasibility II
A study testing Angioshield in people with Coronary Artery Disease, run by Neograft Technologies, Incorporated at 1 site in Lithuania.
Trial summary
Feasibility Study to Demonstrate the Safety of the Angioshield System to Provide Mechanical Support for Vein Grafts Used in CABG Surgery. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Coronary Artery Disease
- What is being tested?
- Angioshield
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 1 siteLithuania
- Study dates
- Nov 2015to 7 Mar 2018
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subject will be eligible for inclusion in the investigation if he/she:
- is between the ages of 18 and 80 years of age, inclusive
- requires CABG surgery due to atherosclerotic coronary artery disease with minimum of two SVGs, one used to bypass a stenosis in the main Right Coronary artery and one used to bypass a stenosis in the Circumflex artery territory
- is able to give their informed written consent
- is willing and able to complete all follow-up visits and procedures
- is to be treated via a medial sternotomy with cardio-pulmonary bypass during surgery
- has adequate saphenous veins
- Is a candidate for transcatheter therapy, PCI
Who cannot join
- Subject will be excluded from participation in the investigation if he/she:
- is currently enrolled in another clinical investigation
- is unable to tolerate or comply with required post-surgical medications or imaging (e.g., anticoagulation regimen; or known allergy to contrast agent)
- is or may be pregnant or is lactating, or plans to become pregnant in the next 12 months
- history of a hypercoagulable state
- has had an acute MI within the last 21 days
Show all 19Show fewer
- has had a previous CABG
- requires emergency surgery
- has a left ventricular ejection fraction (LVEF) less than 35 %
- has a target vessel stenosis of less than 75%
- has a transmural infarct of the target artery territory
- has a serum creatinine greater than 1.5 mg/dL
- is having concomitant -surgery of any kind
- has had previous saphenectomy (See inclusion)
- has saphenous vein sizes incompatible with treatment range (i.e., <3.5 mm or >5 mm inner diameter)
- limb Ischemia or non-healing ulcer
- has moderate to severe COPD defined as FEV 1 of less than 1 liter
- has had a CVA in last 90 days
- has diffuse disease in target vessel with an inadequate anastomotic touchdown site
Trial locations and contacts
1 site in 1 country.
About this study
Official title: THE ANGIOSHIELD STUDY:Feasibility Study to Demonstrate the Safety of the Angioshield System to Provide Mechanical Support for Vein Grafts Used in CABG Surgery
Feasibility Study to Demonstrate the Safety of the Angioshield System to Provide Mechanical Support for Vein Grafts Used in CABG Surgery.
Read the detailed description
The study is designed to investigate the feasibility of using an applied support (Angioshield) to a saphenous vein to be used in Coronary Artery Bypass Surgery. It is a feasibility to determine safety prior to launching a larger pivotal study. The primary endpoint, 30-day safety, will be assessed by recording and reporting of adverse events during surgery and throughout the investigation until the 30-day follow-up visit. The secondary endpoints, long term safety and patency, will be assessed by recording and reporting of adverse events and graft patency (via serial CT angiograms) at the 30, 90, and 365 day follow-up visits.
- Conditions
- Coronary Artery Disease
- Being tested
- Angioshield
- 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.
AngioshieldDevice
Angioshield is applied to vein graft to provide Mechanical Support for Vein Grafts Used in CABG Surgery
| Study group | Role | What they receive |
|---|---|---|
| Right Region | Active comparator | Angioshield will be applied to provide Mechanical Support for Vein Grafts Used in CABG in the right region of the heart Receives: Device: Angioshield |
| Left Region | Active comparator | Angioshield will be applied to provide Mechanical Support for Vein Grafts Used in CABG in the left region of the heart Receives: Device: Angioshield |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety-reported MACE
The primary endpoint, 30 day safety, (MACE) will be assessed by recording and reporting of adverse events during surgery and throughout the investigation until the 30-day follow-up visit
Measured: 30 days
Secondary outcomes (2)
Safety, (MACE) will be assessed by recording and reporting of adverse events at the 30, 90, and 365 day follow-up visits.
Measured: 90 and 365 days
Patency: Graft patency (via serial CT angiograms) will be measured at the 30, 90, and 365 day follow-up visits.
Measured: 30, 90 ,and 365 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Sep 2015 (estimated)
- Study startNov 2015
- Primary completionMar 2017
- Study completion7 Mar 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Artery 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- Neograft Technologies, Incorporated
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Gintaras Kalinauskas, MD, Principal investigator, Santariskiu University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02543047
- Sponsor's protocol ID
- TP14-026
- Status last verified
- Oct 2017
- First submitted
- 2 Sep 2015
- Last updated
- 25 May 2018
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 25 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- THE ANGIOSHIELD STUDY:Feasibility Study to Demonstrate the Safety of the Angioshield System to Provide Mechanical Support for Vein Grafts Used in CABG Surgery
- ClinicalTrials.gov ID
- NCT02543047
- Acronym / sponsor ID
- TP14-026
- Conditions
- Coronary Artery Disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- Neograft Technologies, IncorporatedIndustry (pharma, biotech, devices)
- Study start
- Nov 2015 (actual)
- Primary completion
- Mar 2017 (actual)
- Study completion
- 7 Mar 2018 (actual)
- First posted
- 7 Sep 2015 (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.
Feasibility Study to Demonstrate the Safety of the Angioshield System to Provide Mechanical Support for Vein Grafts Used in CABG Surgery.
Detailed description
The study is designed to investigate the feasibility of using an applied support (Angioshield) to a saphenous vein to be used in Coronary Artery Bypass Surgery. It is a feasibility to determine safety prior to launching a larger pivotal study. The primary endpoint, 30-day safety, will be assessed by recording and reporting of adverse events during surgery and throughout the investigation until the 30-day follow-up visit. The secondary endpoints, long term safety and patency, will be assessed by recording and reporting of adverse events and graft patency (via serial CT angiograms) at the 30, 90, and 365 day follow-up visits.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Right Region | Active comparator | Device: AngioshieldAngioshield will be applied to provide Mechanical Support for Vein Grafts Used in CABG in the right region of the heart |
| Left Region | Active comparator | Device: AngioshieldAngioshield will be applied to provide Mechanical Support for Vein Grafts Used in CABG in the left region of the heart |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- is between the ages of 18 and 80 years of age, inclusive
- requires CABG surgery due to atherosclerotic coronary artery disease with minimum of two SVGs, one used to bypass a stenosis in the main Right Coronary artery and one used to bypass a stenosis in the Circumflex artery territory
- is able to give their informed written consent
- is willing and able to complete all follow-up visits and procedures
- is to be treated via a medial sternotomy with cardio-pulmonary bypass during surgery
Key exclusion criteria (19 listed)
- is currently enrolled in another clinical investigation
- is unable to tolerate or comply with required post-surgical medications or imaging (e.g., anticoagulation regimen; or known allergy to contrast agent)
- is or may be pregnant or is lactating, or plans to become pregnant in the next 12 months
- history of a hypercoagulable state
- has had an acute MI within the last 21 days
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 |
|---|---|---|
| AngioshieldAngioshield is applied to vein graft to provide Mechanical Support for Vein Grafts Used in CABG Surgery | Device | Left Region, Right Region |
Primary outcome
Safety-reported MACE
Time frame: 30 days
The primary endpoint, 30 day safety, (MACE) will be assessed by recording and reporting of adverse events during surgery and throughout the investigation until the 30-day follow-up visit
2 secondary outcomes
Safety, (MACE) will be assessed by recording and reporting of adverse events at the 30, 90, and 365 day follow-up visits.
Time frame: 90 and 365 days
Patency: Graft patency (via serial CT angiograms) will be measured at the 30, 90, and 365 day follow-up visits.
Time frame: 30, 90 ,and 365 days
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 25 May 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.
Gintaras Kalinauskas, MD principal investigator
Santariskiu University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Angioshield in people with Coronary Artery Disease, run by Neograft Technologies, Incorporated at 1 site in Lithuania.
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 19 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 25 May 2018. 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 Lithuania. 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 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?
Safety-reported MACE (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 25 May 2018.