AzTrials
AzTrials

Aortic Aneurysm, ThoracicNCT01357590

Evaluation of Thoraflex in the Treatment of Aneurysm or Penetrating Ulcer of the Descending Thoracic Aorta

A study testing Thoracic Endovascular Stent Graft System (ThoraflexTM) in people with Aortic Aneurysm, Thoracic and Penetrating Aortic Ulcers (PAUs), run by Vascutek Ltd. at 28 sites in 7 countries.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
Search all trials

Trial summary

ThoraflexTM is designed for the treatment of aneurysm or penetrating ulcer of the descending thoracic aorta. Each system is advanced from a transfemoral or transiliac approach over a 0.035" guidewire and positioned under fluoroscopic control. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Thoracic Endovascular Stent Graft System (ThoraflexTM)
Type of treatment
Medical device
How many people
0 participants
Where
28 sitesin 7 countries
Study dates
Start not givento not given
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 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Subject aged > 18 years
  • Subject has a life expectancy of at least 12 months
  • The Subject must meet at least one of the following:
  • Descending thoracic fusiform aneurysm, 50mm in diameter or greater. ONLY FOR FRENCH SITES: Descending thoracic fusiform aneurysm, 5.5cm in diameter or greater.
  • Descending thoracic aneurysm that is 4cm or more in diameter that has increased in size by 0.5cm in last 6 months. ONLY FOR FRENCH SITES: Descending thoracic aneurysm that is 4cm or more in diameter that has increased in size by 1cm in the last year
  • Descending thoracic aneurysm with a maximum diameter that exceeds two times the diameter of the non-aneurysmal, adjacent aorta
Show all 13Show fewer
  • Saccular aneurysm in the descending thoracic aorta or Penetrating Atherosclerotic Ulcers (PAUs). ONLY FOR FRENCH SITES: Saccular aneurysm in the descending thoracic aorta, Penetrating Atherosclerotic Ulcers (PAUs) with associated Intramural Haematoma, or Atherosclerotic Giant PAU
  • Subject must have proximal and distal aortic neck suitable for stent graft placement with vessel diameter ranging between 22.0 - 35.0 mm.
  • The length of attachment zones will depend on the intended stent graft diameter. For left subclavian artery (LSA) in superior position: The proximal attachment zone should be 10mm for 28mm graft, 11mm for 30mm, 12mm for 32mm - 34mm grafts, 14mm for 36mm - 38mm grafts and 15mm for 40mm graft. For LSA in non-superior position: The proximal attachment zone should be 15mm for 28mm graft, 17mm for 30mm, 20mm for 32mm - 34mm grafts, 23mm for 36mm - 38mm grafts and 25mm for 40mm graft. The distal attachment zone should be 40mm.
  • The diagnosis is confirmed as thoracic aortic aneurysm or PAU by contrast enhanced CT obtained within the three months prior to implant.
  • Access vessels: Adequate iliac/femoral access -able to accommodate 23 (7.7 mm) or 25 OD French size (8.3 mm) introducer systems, with or without the use of an arterial conduit.
  • Subject is able and willing to comply with the protocol and associated follow-up requirements
  • Subject or legal representative must have agreed to participate voluntarily and have signed and dated an Ethics Committee/Ethical Review Board approved Patient Informed Consent form.

Who cannot join

  • Subject has any of the following conditions in his/her descending thoracic aorta:
  • Dissections - acute or chronic, in ascending or descending aorta
  • Acute Transection or Acute Traumatic Injury
  • Pseudoaneurysm (false aneurysm)
  • Symptomatic Aneurysm, including ruptured lesions
  • Subject's proximal neck diameter measures < 22.0 or > 35.0 mm.
Show all 29Show fewer
  • Subject's distal neck diameter measures < 22.0 or > 35.0 mm.
  • Subject has prohibitive calcification (>50% circumferential calcification), occlusive disease, or tortuosity of intended fixation sites.
  • Subject has circumferential thrombus (>50%) in region of intended fixation sites.
  • Subject has an increasing tapered proximal neck with ≥3mm increase in diameter from proximal fixation site to the aneurysm.
  • Subject has a decreasing tapered distal neck with ≥3 mm increase in diameter from distal fixation site to the aneurysm.
  • Subject's aneurysm or distal thoracic aortic neck angle precludes advancement of the introduction system and device.
  • Subject has an anatomical variance which would compromise circulation to the carotids, vertebral, or innominate arteries after device placement that is not amenable to subclavian revascularisation. This would not apply to Subjects with occluded celiac arteries.
  • Subject is pregnant.
  • Subject is morbidly obese preventing adequate x-ray visualization of the aorta.
  • Subject has known or suspected connective tissue disorder (e.g., Marfan's syndrome, Ehlers-Danlos syndrome).
  • Subject has a blood coagulation disorder or bleeding diathesis in which the treatment cannot be suspended for one week pre and post repair.
  • Subject has coronary artery disease with unstable angina and who has not received coronary revascularisation within the last 3 months.
  • Subject has chronic obstructive pulmonary disease requiring the routine need for oxygen therapy outside the hospital setting (e.g., daily or nightly home use).
  • Subject is in acute renal failure or renal insufficiency with a creatinine ≥ 2.5 mg/dL and is not on renal replacement therapy or dialysis.
  • Subject has active systemic infection and/or mycotic aneurysms.
  • Subject has had a stroke within 3 months of the treatment date.
  • Subject has less than one-year life expectancy as evidenced by factors prohibiting major medical intervention (e.g., presence of malignant tumour, advanced age, etc.).
  • Subject is participating in another research study.
  • Subject has a co-existing abdominal aortic aneurysm (AAA) in which the investigator believes requires concomitant treatment within 45 days.
  • Subject has had a prior AAA repair (endovascular or surgical) that was performed less than 6 months prior to enrolment.
  • Subject has had a prior endovascular repair (e.g., stent, stent-graft) in the descending thoracic aorta. The device may not be placed within any prior surgical graft.
  • Subject has an untreatable allergy or sensitivity to contrast media or device components.
  • Subject has been admitted to the hospital for a major surgical or medical procedure within45 days of the planned procedure or is planning to undergo other major surgical or medical procedure within 45 days post implantation (e.g., coronary artery bypass graft [CABG], organ transplantation, etc.). This excludes any planned procedures for the prospective stent-graft placement (e.g. common carotid to left subclavian transposition/bypass, left carotid to axillary bypass, etc. are acceptable. Carotid-carotid bypasses are not permitted).

Trial locations and contacts

28 sites in 7 countries.

28 sites in 7 countries

Germany6 sites

  • RWTH Aachen, University Hospital Aachen

    Aachen, 52074

  • Harzzentru der Universitatsklinik Koln

    Cologne, 50924

  • Universitatsklinikum Freiburg

    Freiburg im Breisgau, 79106

  • Department of Vascular Medicine

    Hamburg, 20246

  • MH Hannover

    Hanover, 30625

  • Klinikum rechts der Isar

    Munich, 81675

Other trials in Germany

Netherlands5 sites

  • VUmc, Department of Surgery

    Amsterdam, 1081 HV

  • Academic Medical Centre (AMC), Department of Surgery

    Amsterdam, 1105 AZ

  • Medisch Specturm Twente, Department of Surgery

    Enschede, 7513 ER

  • University of Maastricht, Department of Surgery

    Maastricht, 6229 HX

  • Erasmus Medical Centre, Department of Surgery

    Rotterdam, 3015 CE

Other trials in Netherlands

Canada4 sites

  • Peter Lougheed Centre

    Calgary, AB T1Y 6J4

  • Institute University de Cardiologie et de

    Québec, G1V 4G5

  • Sunnybrook Health Sciences Centre

    Toronto, M4N 3M5

  • St Michael's Hospital

    Toronto, ON M5B 1W

Other trials in Canada

United Kingdom4 sites

  • Royal Infirmary of Edinburgh

    Edinburgh, Scotland, ED16 4SA

  • Western Infirmary

    Glasgow, G11 6NT

  • Leeds General Infirmary

    Leeds, England, LS1 3EX

  • St Thomas' Hospital

    London, SE1 7EH

Other trials in United Kingdom

Belgium3 sites

  • Cliniques Universitaires Saint-Luc (UCL)

    Brussels, B-1200

  • UZ Gent

    Ghent, B-9000

  • UZ (Universitair Ziekenhuis) Leuven

    Leuven, 3000 Leuven

Other trials in Belgium

France3 sites

  • Service de Chirurgie Cardaque et Vasculaire

    Bordeaux, 33 604

  • Hopital Europeen Georges Pompidou

    Paris, 75908

  • Service de Radiologie

    Toulouse, 31403

Other trials in France

Italy3 sites

  • Universita di Bologna

    Bologna, 41038

  • University of Florence

    Florence, 50134

  • Dipartimento Cardioscienze

    Rome, 00152

Other trials in Italy

About this study

Official title: Evaluation of the Vascutek Ltd. Thoracic Endovascular Stent Graft System (ThoraflexTM)in the Treatment of Aneurysm or Penetrating Ulcer of the Descending Thoracic Aorta

ThoraflexTM is designed for the treatment of aneurysm or penetrating ulcer of the descending thoracic aorta. Each system is advanced from a transfemoral or transiliac approach over a 0.035" guidewire and positioned under fluoroscopic control. If necessary, an arterial conduit technique may be required to allow access to the arterial system. The soft tapered tip allows atraumatic insertion into the vessel, while the catheter and sheath are designed to provide excellent flexibility and control through tortuous arterial anatomy.

Each individual stent graft device is supplied sterile and pre-loaded in a single-use delivery system. The stent graft is a self-expanding endoprosthesis constructed of a thin wall woven polyester and nitinol ring stents, which are attached to the fabric with braided polyester sutures. The delivery system central catheter is a stainless steel braided co-extrusion of polytetrafluoroethylene (PTFE) and polyester elastomer, designed to provide significant torque control and strength, while also maintaining superior flexibility. The outer sheath is made in a tri-layer construction consisting of a PTFE liner, a stainless steel flat braid layer and a polyester elastomer outer jacket with a hydrophilic lubricant coating. These materials provide very low friction force during device insertion and deployment together with enhanced flexibility of the delivery system. The handle components are moulded from thermoplastic polyurethane.

Read more

The materials of the endoprosthesis are identical to those of the current Conformité Européenne (CE) marked Vascutek Ltd. AnacondaTM Stent Graft System intended for abdominal aortic aneurysm repair. The materials of the delivery system are well established in medical applications. The design of ThoraflexTM is based on the same principles as other clinically established thoracic endovascular devices. The endoprosthesis is constructed of self-expanding nitinol stents and a polyester tube graft. Four proximal hooks anchor the endoprosthesis within the aorta. Unlike existing thoracic endovascular devices, the delivery system of ThoraflexTM allows repositioning of the endoprosthesis so that the optimal deployment position can be enhanced.

The intended use of ThoraflexTM is the treatment of aneurysm or penetrating ulcer of the descending thoracic aorta, which is identical to other CE approved thoracic endovascular devices.

Being tested
Thoracic Endovascular Stent Graft System (ThoraflexTM)
Keywords
aneurysm, penetrating ulcer, descending thoracic aorta
Medical subject headings
Aortic Aneurysm, Thoracic, Penetrating Atherosclerotic Ulcer, Aneurysm

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Thoracic Endovascular Stent Graft System (ThoraflexTM)Device

    Thoracic Endovascular Stent Graft System

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Successful aneurysm/PAU treatment, defined as a composite endpoint of Subjects who have successful delivery and deployment of the ThoraflexTM at the initial procedure and are free from the following;

    1. Aneurysm growth (greater than or equal to) 5mm from baseline measurement
    2. Post-operative interventions to correct type I or III endoleaks
    3. Conversion to open surgical repair
    4. Failed patency of the stent graft
    5. Migration requiring secondary intervention
    6. Significant failure of stent graft integrity
    7. Aneurysm rupture

    Measured: (less than or equal to) 365 days post-procedure

Secondary outcomes (3)

  1. Incidence of type I or III endoleak. The incidence of Subjects with freedom from type I and III endoleaks will be the focus of assessments; however type II and IV endoleaks will be recorded and evaluated for rates of occurrence

    Measured: First 24 hour post-operative period (defined on procedural angiography)

  2. Stent graft patency, described as the presence of blood flow within the graft as determined through imaging analysis

    Measured: First 24 hour post-operative period (defined on procedural angiography)

  3. Conversion to surgical repair

    Measured: First 24 hour post-operative period (defined on procedural angiography)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 May 2011 (estimated)

Resources

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
Non-randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01357590
Sponsor's protocol ID
TAA-001
Status last verified
Mar 2012
First submitted
17 May 2011
Last updated
2 Mar 2012
Results posted
No
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A study testing Thoracic Endovascular Stent Graft System (ThoraflexTM) in people with Aortic Aneurysm, Thoracic and Penetrating Aortic Ulcers (PAUs), run by Vascutek Ltd. at 28 sites in 7 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 13 inclusion and 29 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: withdrawn, as of the sponsor's last update on 2 Mar 2012. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 28 sites in Germany, Netherlands, Canada, United Kingdom, Belgium and 2 more countries. 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 withdrawn before enrolling participants, so there are no results.

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?

Successful aneurysm/PAU treatment, defined as a composite endpoint of Subjects who have successful delivery and deployment of the ThoraflexTM at the initial procedure and are free from the following; (time frame: (less than or equal to) 365 days post-procedure). 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 NCT01357590.

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 2 Mar 2012.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in