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

NCT01357590 | Withdrawn DMC

• 1 other identifier: TAA-001
• Study Type: interventional
• Target: N/A
• Locations: 7 countries
• Sites: 28

Brief 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. 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. 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.

Conditions

Aortic Aneurysm, Thoracic; Penetrating Aortic Ulcers (PAUs)

Keywords

aneurysm, penetrating ulcer, descending thoracic aorta

Outcome Measures

Primary Outcomes (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

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

Secondary Outcomes (3)

• 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

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

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

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

• Conversion to surgical repair

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

Interventions

Thoracic Endovascular Stent Graft System (ThoraflexTM) DEVICE

Thoracic Endovascular Stent Graft System

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Vascutek Ltd.: lead

Study Sites (28)

Cliniques Universitaires Saint-Luc (UCL)

Brussels, B-1200, Belgium

Location

UZ Gent

Ghent, B-9000, Belgium

Location

UZ (Universitair Ziekenhuis) Leuven

Leuven, 3000 Leuven, Belgium

Location

Peter Lougheed Centre

Calgary, AB T1Y 6J4, Canada

Location

Institute University de Cardiologie et de

Québec, G1V 4G5, Canada

Location

Sunnybrook Health Sciences Centre

Toronto, M4N 3M5, Canada

Location

St Michael's Hospital

Toronto, ON M5B 1W, Canada

Location

Service de Chirurgie Cardaque et Vasculaire

Bordeaux, 33 604, France

Location

Hopital Europeen Georges Pompidou

Paris, 75908, France

Location

Service de Radiologie

Toulouse, 31403, France

Location

RWTH Aachen, University Hospital Aachen

Aachen, 52074, Germany

Location

Harzzentru der Universitatsklinik Koln

Cologne, 50924, Germany

Location

Universitatsklinikum Freiburg

Freiburg im Breisgau, 79106, Germany

Location

Department of Vascular Medicine

Hamburg, 20246, Germany

Location

MH Hannover

Hanover, 30625, Germany

Location

Klinikum rechts der Isar

Munich, 81675, Germany

Location

Universita di Bologna

Bologna, 41038, Italy

Location

University of Florence

Florence, 50134, Italy

Location

Dipartimento Cardioscienze

Rome, 00152, Italy

Location

VUmc, Department of Surgery

Amsterdam, 1081 HV, Netherlands

Location

Academic Medical Centre (AMC), Department of Surgery

Amsterdam, 1105 AZ, Netherlands

Location

Medisch Specturm Twente, Department of Surgery

Enschede, 7513 ER, Netherlands

Location

University of Maastricht, Department of Surgery

Maastricht, 6229 HX, Netherlands

Location

Erasmus Medical Centre, Department of Surgery

Rotterdam, 3015 CE, Netherlands

Location

Leeds General Infirmary

Leeds, England, LS1 3EX, United Kingdom

Location

Royal Infirmary of Edinburgh

Edinburgh, Scotland, ED16 4SA, United Kingdom

Location

Western Infirmary

Glasgow, G11 6NT, United Kingdom

Location

St Thomas' Hospital

London, SE1 7EH, United Kingdom

Location

MeSH Terms

Conditions

Aortic Aneurysm, Thoracic; Penetrating Atherosclerotic Ulcer; Aneurysm

Condition Hierarchy (Ancestors)

Aortic Aneurysm; Vascular Diseases; Cardiovascular Diseases; Aortic Diseases; Acute Aortic Syndrome; Arteriosclerosis; Arterial Occlusive Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 17, 2011
• First Posted: May 20, 2011
• Last Updated: March 2, 2012

Record last verified: 2012-03

Locations

DE (6); FR (3); IT (3); NL (5); GB (4); BE (3); CA (4)