Trial record 14 of 84 for:    Open Studies | "Aortic Aneurysm, Abdominal"

HORIZON CE Pivotal Study to Treat Abdominal Aortic Aneurysm

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2014 by Endospan Ltd.
Sponsor:
Information provided by (Responsible Party):
Endospan Ltd.
ClinicalTrials.gov Identifier:
NCT02087501
First received: March 10, 2014
Last updated: May 7, 2014
Last verified: March 2014
  Purpose

Clinical Investigation Design A prospective, open-label, non-randomized, interventional clinical study, sponsored by Endospan Ltd. Patients will be followed-up for five years.

Investigational Device The Horizon™ Abdominal Aortic Aneurysm Stent Graft System and its designated Delivery System.

Purpose The purpose of the study is to evaluate the safety and performance of the Horizon™ AAA Stent Graft System for the treatment of infrarenal abdominal aortic and/or aortoiliac aneurysms. The results of this study will be used as supportive data for CE Marking submission in the European Union (EU).

Objectives The primary objectives of the study are to evaluate the safety and performance of the Horizon™ AAA Stent graft System.

Primary End Points Safety endpoints include proportion of patients free from device related Major Adverse Events (MAEs) within 1 month of the endovascular procedure. Performance endpoints include successful delivery and deployment of the device; and absence of the following at 1 month follow-up: aneurysm growth ≥5mm, type I or III endoleaks, stent graft occlusion, conversion to open surgery, rupture and stent graft migration.

Subject population Thirty (30) patients having infrarenal abdominal aortic and/or aortoiliac aneurysms, having Iliac/femoral access vessel morphology that is compatible with vascular access techniques and devices.

Treatment All patients will be treated by implantation of the Horizon™ Abdominal Aortic Aneurysm Stent graft System.


Condition Intervention
Infrarenal Abdominal Aortic Aneurysms
Aortoiliac Aneurysms
Device: Horizon™ Abdominal Aortic Aneurysm Stent Graft System

Study Type: Interventional
Study Design: Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Prospective Open-label Non-randomized Pivotal Study to Evaluate the Safety and Performance of the Horizon™ Abdominal Aortic Aneurysm (AAA) Stent Graft System

Resource links provided by NLM:


Further study details as provided by Endospan Ltd.:

Primary Outcome Measures:
  • Safety endpoint: Major adverse events [ Time Frame: 1 month post implantation ] [ Designated as safety issue: Yes ]
    Safety endpoint includes proportion of patients free from MAEs within 1 month post implantation, as adjudicated by an independent clinical events committee (CEC).

  • Performance endpoint [ Time Frame: 1 month post implant ] [ Designated as safety issue: No ]

    Performance endpoints will assess the rate of successful aneurysm treatment at 1 month, defined as:

    • Successful delivery and deployment of the device.
    • Absence of the following, as determined by an independent core-lab: aneurysm growth ≥5mm, type I or III endoleaks, stent graft occlusion, conversion to open surgery, rupture and clinically significant stent graft migration.


Secondary Outcome Measures:
  • MAEs [ Time Frame: 1 month - 5 years post implantation ] [ Designated as safety issue: Yes ]
    Proportion of patients free from MAEs at 1 month through 5 years post implantation.

  • Mortality [ Time Frame: 1 - 12 months ] [ Designated as safety issue: Yes ]
    All-cause mortality and aneurysm-related mortality through 1 and 12 months, Kaplan-Meier survival analysis.

  • secondary performance endpoint [ Time Frame: 0 - 12 months post implantation ] [ Designated as safety issue: No ]
    Absence of all of the following at 1 year: aneurysm growth ≥5mm, type I or III endoleaks, stent graft occlusion, conversion to open surgery, rupture and stent graft migration.


Estimated Enrollment: 30
Study Start Date: April 2014
Estimated Study Completion Date: November 2019
Estimated Primary Completion Date: November 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
HORIZON AAA Stent Graft
All patients will received the HORIZON AAA Stent Graft
Device: Horizon™ Abdominal Aortic Aneurysm Stent Graft System
All patient eligible to undergo stent implantation will receive the Horizon™ Abdominal Aortic Aneurysm Stent Graft System and its designated Delivery System.

Detailed Description:

Possible benefits:

It is believed that the Horizon™ AAA Stent Graft System implantation may offer a number of benefits over conventional and recently developed treatment options for patients suffering from AAA. These other treatment modalities include open surgery and the more recently evolved EVAR.

The Horizon™ AAA Stent graft System has a low profile of 14Fr and is implanted through a percutaneous approach. The modular bottom-up construction requires a single-sided femoral access and there is no need for cannulation of the contralateral limb, a requirement present in the majority of commercially available devices. These features are anticipated to result in a simplified procedure with less surgical trauma, shorter procedure time, lower levels of radiation exposure and shorter hospitalization periods. Moreover, the device is flexible enough to reach also tortuous anatomies and its fixation elements reduce the concern of migration and type I endoleaks.

As such, it is believed that the Horizon™ AAA Stent graft System may have potential clinical advantages and may exhibit benefits over commercially available stent-grafts.

Hypothesis:

In this clinical study safety and performance primary endpoints are compared between HORIZON™ and those reported for the Lifeline Registry of Endovascular Aneurysm Repair (Control).

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Male and female age ≥ 18.
  2. Presence of at least one of the following:

    i. Abdominal aortic aneurysm ≥ 5.0cm in diameter (perpendicular to the line of flow).

    ii. Abdominal aortic aneurysm 4.5-5.5cm in diameter which increased in size - ≥ 0.5cm over 6 months or 1.0cm over one year.

    iii. Abdominal aortic aneurysm >50% larger than the normal aortic diameter.

  3. Patient is considered an appropriate candidate for an elective surgery, as evaluated by Physical Status Classification System I, II or III (American Society of Anesthesiologists).
  4. Femoral artery diameter of ≥6mm, documented by CTA or MRA that allows endovascular access to the aneurismal site with a 14 Fr delivery catheter.
  5. Access vessels morphology suitable for endovascular repair in terms of tortuosity, calcification and angulation, documented by CTA or MRA.
  6. To be eligible to receive the Horizon having the following characteristics, as demonstrated on CTA or MRA imaging:

I. Infrarenal aortic diameter of 18-28 mm II. Aortic length (lower renal artery to lowest point of aortic bifurcation) of 115-150 mm III. Iliac artery diameter of 10-19 mm IV. Proximal aortic neck length ≥ 15 mm V. Proximal aortic neck angulation ≤ 60° VI. Diameter measured 20mm above aortic bifurcation floor should be ≥ 20mm VII. Aortic bifurcation angulation of ≥ 70°. 7. Patient understands and is voluntarily willing to participate as evidenced by personally signing the Informed Consent document.

Exclusion Criteria:

  1. If female and of childbearing potential , patients who are:

    1. pregnant (as determined by a positive pregnancy test performed between 10 to 5 days before implantation date), or
    2. intend to become pregnant during the study period, or
    3. do not accept to use adequate double barrier contraception methods for the entire study duration to avoid pregnancy
  2. Life expectancy of less than 1 year.
  3. Any medical condition that, according to the investigator's decision, might expose the patient to increased risk by the investigational device or procedure.
  4. Patient is in need for an emergent surgery for a ruptured aneurysm.
  5. Patient with an increased risk for aneurysm rupture, such as, saccular aneurysm, aneurysm with isolated wall protrusion and penetrating ulcers of the aorta.
  6. A dissecting, acutely ruptured, or leaking aneurysm, or an acute vascular injury due to trauma.
  7. Presence of thrombus or atheroma in proximal aortic neck covering >50% of the endoluminal surface.
  8. Presence of diffuse atherosclerotic disease in either common iliac artery that reduces the iliac artery diameter to <6mm.
  9. Congenital vascular disease in which the placement of the stent graft will cause occlusion of major arterial flow.
  10. Aneurysm with any of the following characteristics: suprarenal, isolated ilio-femoral, mycotic, inflammatory or para-anastomotic pseudoaneurysm.
  11. Patient has an untreated thoracic aneurysm > 5.5 cm in diameter.
  12. Patient has an aneurysm that involves the part of the aorta at the ostia of the renal arteries.
  13. Patient has a reversed conical neck defined as a > 4mm distal increase over a 10 mm length.
  14. Patient has ectatic iliac arteries requiring bilateral exclusion of hypogastric blood flow.
  15. Patient whose arterial access site is not anticipated to accommodate the 14 Fr diameter of the Horizon™ Delivery System, due to size, tortuosity or hostile groins (scarring, obesity, or previous failed puncture).
  16. Patient underwent major surgery or interventional procedure in the last three months.
  17. Patient is suffering from unstable angina.
  18. Patient has had a myocardial infarction (MI) or cerebral vascular accident (CVA) within 3 months prior to the planned implantation.
  19. Patient has a known hypersensitivity or contraindication to anticoagulants, antiplatelets, or contrast media, which is not amenable to pre-treatment.
  20. Contraindication to undergoing angiography.
  21. Patients with known hypersensitivity or allergy to device materials - Nitinol and Polyester.
  22. Morbid obesity or other clinical conditions that severely inhibit x-ray visualization of the aorta.
  23. Connective tissue disease (e.g., Marfan's or Ehler's-Danlos syndromes).
  24. Patient has a history of bleeding diathesis or coagulopathy.
  25. Active systemic infection at the time of the index procedure documented by either one of the following: pain, fever, drainage, positive culture and/or leukocytosis (WBC > 11,000 mm3).
  26. Acute renal failure documented by either one of the following: Creatinine > 2.00 mg/dl or > 182 pmol/L; patient on dialysis.
  27. Any other medical, social, or psychological issues that in the opinion of the investigator preclude them from receiving this treatment, or the procedures and evaluations pre- and post- treatment.
  28. Active participation in another research study involving an investigational device or new drug.

    -

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02087501

Contacts
Contact: Orly Schwartz +972 (0) 9 7884490 orly@endospan.com
Contact: Simona Beilin-Nissan +972 (0) 9 7884490 simona@endospan.com

Locations
Germany
Park-Krankenhaus Leipzig Not yet recruiting
Leipzig, Sachsen, Germany, 04289
Contact: Dierk Scheinert, MD    0341 864-2269    dierk.scheinert@parkkrankenhaus-leipzig.de   
Principal Investigator: Prof. Dr. Dierk Scheinert, MD         
Israel
Barzili Medical Center - Vascular Surgery Not yet recruiting
Ashkelon, Israel, 78278
Contact: Prof. Boris Yoffe    +972 08 6745656    yoffe@barzi.health.gov.il   
Principal Investigator: Prof. Boris Yoffe, MD         
Hadassah Medical Center - Vascular Surgery Not yet recruiting
Jerusalem, Israel, 91120
Contact: Chen Rubinstein, MD    +972 2 6777111    chenr@hadassah.org.il   
Principal Investigator: Dr. Chen Rubinstein, MD         
Italy
Nuovo Ospedale Civile S. Agostino Estense - Chirurgia vascolare Not yet recruiting
Modena, Italy, 41126
Contact: Prof. Gioachino Coppi, MD    +39 05903961224    gioachino.coppi@unimore.it   
Principal Investigator: Gioacchino Coppi, MD         
Netherlands
Catharina Ziekenhuis Eindhoven - department of vascula surgery Recruiting
Eindhoven, Netherlands, 5623
Contact: Dr. Marc Van Sambeek    040 2396349    marc.v.sanbeek@catharinaziechenhuis.nl   
Principal Investigator: Dr. Marc Van Sanbeek, MD         
Switzerland
Zurich University Hospital- Klinik für Herz- und Gefässchirurgie Not yet recruiting
Zurich, Switzerland, 8091
Contact: Prof. Mario Lachat    +41 442553381    mario.lachat@usz.ch   
Principal Investigator: Prof Mario Lachat, MD         
Sponsors and Collaborators
Endospan Ltd.
  More Information

No publications provided

Responsible Party: Endospan Ltd.
ClinicalTrials.gov Identifier: NCT02087501     History of Changes
Other Study ID Numbers: CIP003.00
Study First Received: March 10, 2014
Last Updated: May 7, 2014
Health Authority: Germany: Ministry of Health
Italy: Ministry of Health
Israel: Ministry of Health
Switzerland: Swissmedic
Netherlands: Ministry of Health, Welfare and Sport

Keywords provided by Endospan Ltd.:
Abdominal Aortic Aneurysm
AAA
Abdominal Aortoiliac Aneurysm
Endovascular Aortic Repair
EVAR

Additional relevant MeSH terms:
Aneurysm
Aortic Aneurysm
Aortic Aneurysm, Abdominal
Vascular Diseases
Cardiovascular Diseases
Aortic Diseases

ClinicalTrials.gov processed this record on July 22, 2014