Aneurysmal Disease of the Ascending Aorta, the Arch and the Proximal Descending AortaPhase 1/2NCT01541410
Evaluation of the Vascutek Hybrid Graft for Use in the Replacement of the Aortic Arch and Concomitant Treatment of an Aneurysm/Dissection of the Descending Aorta in the Frozen Elephant Trunk Procedure
A Phase 1/2 study testing Vascutek Hybrid Graft in people with Aneurysmal Disease of the Ascending Aorta, the Arch and the Proximal Descending Aorta, run by Vascutek Ltd. at 1 site in Germany.
Trial summary
The purpose of this feasibility study is to investigate the clinical performance of the Vascutek Hybrid Device in the treatment of subjects with aneurysm and/or dissection of the thoracic aorta. Read more about this study
- Who is it for?
- Ages 29 to 79 years
- Conditions the study is for
- Aneurysmal Disease of the Ascending Aorta, the Arch and the Proximal Descending Aorta
- What is being tested?
- Vascutek Hybrid Graft
- Type of treatment
- Medical device
- How many people
- 34 participants
- Where
- 1 siteGermany
- Study dates
- May 2010to Aug 2011
- Phase
- Phase 1/2
- 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 29 to 79 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with aneurysm and/or dissection of the aortic arch and/or descending aorta
- Patient must have agreed to participate voluntarily and have signed and dated an Ethics Committee approved Patient Informed Consent
- Patient is able and willing to comply with the protocol and associated follow-up requirements
Who cannot join
- Patients unfit for open surgical repair involving circulatory arrest
- Endocarditis or active infective disorder of the aorta
- Patients unwilling to give informed consent
Trial locations and contacts
1 site in 1 country.
Germany1 site
Division of Thoracic and Cardiovascular Surgery, Hannover Medical School
Hanover, 30625
About this study
The purpose of this feasibility study is to investigate the clinical performance of the Vascutek Hybrid Device in the treatment of subjects with aneurysm and/or dissection of the thoracic aorta.
Read the detailed description
The Vascutek Hybrid device is designed for use during a frozen elephant trunk procedure. Each system is comprised of a fully sealed traditional prosthesis which is stented at the distal end. A minimum of 10 and a maximum of 30 patients with aneurysmal disease of the ascending aorta, the arch and the proximal descending aorta will receive a hybrid prosthesis implanted without the use of the delivery system and a minimum of 10 patients and a maximum of 20 patients will be implanted with a hybrid device using the delivery system.
The traditional prosthesis component is representative of current Gelweave™ product. It is a woven polyester graft, crimped to maintain the lumen and gel coated to ensure that it will seal immediately. The stented section of the graft is a self-expanding endoprosthesis constructed of a thin wall woven polyester and Nitinol ring stents, which are attached to fabric with braided polyester sutures.
The delivery system is a central catheter comprised of a stainless steel braided, Isoplast-Pebax co-extrusion which has been locally strengthened to provide adequate guidewire lumen and sufficient stiffness to deploy the device. The outer sheath is 24Fr extruded PTFE with a groove to provide a localised splitting during deployment. The handle components are moulded in K-Resin \& thermoplastic polyurethane to fulfil the functional requirements of the product.
The compacted endoprosthesis is placed through the opened aortic arch and deployed leaving the stented section positioned inside the descending aorta. The device is then released from the delivery system and the handle components removed leaving the full graft in situ and correctly positioned. This allows the surgeon to complete the aortic arch repair as required.
The materials of the endoprosthesis section, and of the traditional prosthesis section of the Hybrid Device are identical to those of current Vascutek product (Anaconda™ Stent Graft System - endoprosthesis; and Gelweave™ - standard vascular graft). All materials used in the delivery system are well established in medical applications.
The Vascutek Ltd. Hybrid Device is produced using established manufacturing and Quality Control methodologies in an ISO 9001 and ISO 13485 certified system. The Hybrid Device is provided sterile for single use only. The method of sterilisation is ethylene oxide.
- Being tested
- Vascutek Hybrid Graft
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vascutek Hybrid GraftDevice
Single Group Assignment
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary Safety Endpoint
The primary safety endpoint will be the proportion of subjects free from paraplegia, secondary conversion to conventional open surgical repair and death due to device or procedure related complications ≤30 days post-procedure.
Measured: ≤30 days
Primary Effectiveness Endpoint
The primary effectiveness endpoint will be successful aneurysm treatment, defined as a composite endpoint of subjects who have successful delivery and deployment of the Vascutek Hybrid Device at the initial procedure and at ≤365 days post-procedure.
Measured: ≤365 days
Secondary outcomes (2)
Technical Success
Technical success is defined as the placement and deployment of a Vascutek Hybrid Device in the absence of mortality, conversion to conventional open surgical repair, failed patency, evidence of an unanticipated distal type I or a type III endoleak on pre-discharge CT scan.
Measured: Pre-discharge, 6 and 12 months
Assessment of Stent Graft Migration and Integrity
Stent graft migration will be defined as stent graft migration in excess of 10mm which requires secondary intervention. Structural integrity will be assessed primarily from plain x-ray and CT scan images and will be represented in binomial fashion.
Measured: Pre-discharge, 6 and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Mar 2012 (estimated)
- Study startMay 2010
- Primary completionAug 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Aneurysmal Disease of the Ascending Aorta, the Arch and the Proximal Descending AortaStudies 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 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vascutek Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01541410
- Sponsor's protocol ID
- HYBRID-001
- Status last verified
- Jul 2013
- First submitted
- 13 Feb 2012
- Last updated
- 15 Jul 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 15 Jul 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Vascutek Hybrid Graft for Use in the Replacement of the Aortic Arch and Concomitant Treatment of an Aneurysm/Dissection of the Descending Aorta in the Frozen Elephant Trunk Procedure
- ClinicalTrials.gov ID
- NCT01541410
- Acronym / sponsor ID
- HYBRID-001
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- Vascutek Ltd.Industry (pharma, biotech, devices)
- Study start
- May 2010
- Primary completion
- Aug 2011 (actual)
- First posted
- 1 Mar 2012 (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.
The purpose of this feasibility study is to investigate the clinical performance of the Vascutek Hybrid Device in the treatment of subjects with aneurysm and/or dissection of the thoracic aorta.
Detailed description
The Vascutek Hybrid device is designed for use during a frozen elephant trunk procedure. Each system is comprised of a fully sealed traditional prosthesis which is stented at the distal end. A minimum of 10 and a maximum of 30 patients with aneurysmal disease of the ascending aorta, the arch and the proximal descending aorta will receive a hybrid prosthesis implanted without the use of the delivery system and a minimum of 10 patients and a maximum of 20 patients will be implanted with a hybrid device using the delivery system.
The traditional prosthesis component is representative of current Gelweave™ product. It is a woven polyester graft, crimped to maintain the lumen and gel coated to ensure that it will seal immediately. The stented section of the graft is a self-expanding endoprosthesis constructed of a thin wall woven polyester and Nitinol ring stents, which are attached to fabric with braided polyester sutures.
The delivery system is a central catheter comprised of a stainless steel braided, Isoplast-Pebax co-extrusion which has been locally strengthened to provide adequate guidewire lumen and sufficient stiffness to deploy the device. The outer sheath is 24Fr extruded PTFE with a groove to provide a localised splitting during deployment. The handle components are moulded in K-Resin \& thermoplastic polyurethane to fulfil the functional requirements of the product.
The compacted endoprosthesis is placed through the opened aortic arch and deployed leaving the stented section positioned inside the descending aorta. The device is then released from the delivery system and the handle components removed leaving the full graft in situ and correctly positioned. This allows the surgeon to complete the aortic arch repair as required.
The materials of the endoprosthesis section, and of the traditional prosthesis section of the Hybrid Device are identical to those of current Vascutek product (Anaconda™ Stent Graft System - endoprosthesis; and Gelweave™ - standard vascular graft). All materials used in the delivery system are well established in medical applications.
The Vascutek Ltd. Hybrid Device is produced using established manufacturing and Quality Control methodologies in an ISO 9001 and ISO 13485 certified system. The Hybrid Device is provided sterile for single use only. The method of sterilisation is ethylene oxide.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 29 to 79 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients with aneurysm and/or dissection of the aortic arch and/or descending aorta
- Patient must have agreed to participate voluntarily and have signed and dated an Ethics Committee approved Patient Informed Consent
- Patient is able and willing to comply with the protocol and associated follow-up requirements
Key exclusion criteria (3 listed)
- Patients unfit for open surgical repair involving circulatory arrest
- Endocarditis or active infective disorder of the aorta
- Patients unwilling to give informed consent
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 |
|---|---|---|
| Vascutek Hybrid GraftSingle Group Assignment | Device | – |
Primary outcome
Primary Safety Endpoint
Time frame: ≤30 days
The primary safety endpoint will be the proportion of subjects free from paraplegia, secondary conversion to conventional open surgical repair and death due to device or procedure related complications ≤30 days post-procedure.
Primary Effectiveness Endpoint
Time frame: ≤365 days
The primary effectiveness endpoint will be successful aneurysm treatment, defined as a composite endpoint of subjects who have successful delivery and deployment of the Vascutek Hybrid Device at the initial procedure and at ≤365 days post-procedure.
2 secondary outcomes
Technical Success
Time frame: Pre-discharge, 6 and 12 months
Assessment of Stent Graft Migration and Integrity
Time frame: Pre-discharge, 6 and 12 months
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 15 Jul 2013.
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Vascutek Hybrid Graft in people with Aneurysmal Disease of the Ascending Aorta, the Arch and the Proximal Descending Aorta, run by Vascutek Ltd. 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 3 inclusion and 3 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 15 Jul 2013. 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 combined 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.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Primary Safety Endpoint (time frame: ≤30 days). 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?
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 15 Jul 2013.