AzTrials
AzTrials

Carotid Artery DiseaseASTINCT01133327

Adapt Monorail Carotid Stent System: A Postmarket Clinical Follow-up Study

A study testing Carotid Artery Stenting in people with Carotid Artery Disease and Carotid Stenosis, run by Boston Scientific Corporation at 11 sites in 3 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

The purpose of this study is to get outcomes data for the Adapt Monorail Carotid System used in conjunction with the FilterWire Embolic protection system for treatment of patients that suffer from carotid artery stenosis and that cannot have surgery due to high risk factors. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Carotid Artery Disease, Carotid Stenosis, Stroke
What is being tested?
Carotid Artery Stenting
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
100 participants
Where
11 sitesin 3 countries
Study dates
Jun 2010to Jun 2012
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

  • High-risk for carotid endarterectomy due to anatomical or co-morbid conditions and either has neurological symptoms and ≥ 50% stenosis, via angiography or is asymptomatic and has ≥ 80% stenosis, via angiography
  • Target lesion located in the common carotid artery (CCA), internal carotid artery (ICA), or carotid bifurcation
  • Arterial segment to be stented has a diameter between 4mm and 9mm
  • Age ≥ 18 years
  • Life expectancy > 12 months from the date of the index procedure

Who cannot join

  • Contraindication to percutaneous transluminal angioplasty (PTA)
  • Severe vascular tortuosity or anatomy that would preclude the safe introduction of a guide catheter, sheath, embolic protection system or stent system
  • Lesions in the ostium of the common carotid artery
  • Occlusion of the target vessel
  • Evidence of intraluminal thrombus
  • Known sensitivity to nickel-titanium
Show all 13Show fewer
  • Known allergy to heparin, aspirin or other anticoagulant/ antiplatelet therapies, or is unable or unwilling to tolerate such therapies
  • Uncorrectable bleeding disorders, or will refuse blood transfusions
  • History of prior life-threatening contrast media reaction
  • Previous stent placement in the target vessel
  • Evolving stroke or intracranial hemorrhage
  • Previous intracranial hemorrhage or brain surgery within the past 12 months
  • Clinical condition that makes endovascular therapy impossible or hazardous

Trial locations and contacts

11 sites in 3 countries.

11 sites in 3 countries

Germany6 sites

  • Königin Elisabeth Herzberge

    Berlin, D-10365

  • Klinikum Dortmund

    Dortmund, D-44137

  • Universitaetsklinikum Heidelberg

    Heidelberg, D69120

  • Park KH

    Leipzig, D-04289

  • Klinikum Neuperlach Munich

    Munich, D-81737

  • Radiologische Universitätklinik

    Tübingen, D-72076

Other trials in Germany

Belgium3 sites

  • Imelda Ziekenhuis

    Bonheiden, B-9200

  • A.Z. Sint Blasius

    Dendermonde, East-Flanders, 9200

  • CHU Sart Tilman

    Liège, B-400

Other trials in Belgium

Spain2 sites

  • Hospital Juan Canalejo

    A Coruña, 15174

  • Complejo Hospitalario de Toledo

    Toledo, S-45004

Other trials in Spain

About this study

Official title: Adapt™ Monorail™ Carotid Stent System: A Postmarket Clinical Follow-up Study

The purpose of this study is to get outcomes data for the Adapt Monorail Carotid System used in conjunction with the FilterWire Embolic protection system for treatment of patients that suffer from carotid artery stenosis and that cannot have surgery due to high risk factors.

Read the detailed description

According to the World Health Organization, 15 million people suffer stroke each year. Of these, 5 million die and another 5 million are permanently disabled. Predominant mechanism responsible for stroke is embolism from proximal rupture of atherosclerotic plaque and thrombus. 25-30% of stroke deaths related to the carotid stenosis. The primary therapy for carotid occlusive disease is the surgical removal of this atherosclerotic plaque from inside the artery. Another treatment option for subjects with significant surgical risk factors has been found: the carotid artery stenting is a non-surgical procedure which unblocks narrowing of the carotid artery lumen by inserting a small metal tube (stent) to keep the plaque against the wall of the artery to improve blood flow.

Being tested
Carotid Artery Stenting
Keywords
Carotid Artery Stenting, High Risk patient, Carotid artery stenosis, stroke, Carotid artery disease, ASTI study, Adapt Carotid Stent system, FilterWire EZ Embolic Protection System
Medical subject headings
Carotid Artery Diseases, Carotid Stenosis, Stroke

What participants receive

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

  • Carotid Artery StentingDevice

    Also called Adapt Monorail Carotid Stent system 21mm, 32mm, 40mm, FilterWire Embolic Protection System 3.5 mm - 5.5 mm

    The Adapt Carotid Stent System is intended to deliver a self-expanding Stent to the extra-cranial carotid arteries via a sheathed percutaneous Monorail delivery system. The Adapt Carotid Stent is a closed cell, self-expanding, rolled nitinol (nickel-titanium alloy) sheet. The stent is thin, flexible and expands to appose the vessel wall.

    The FilterWire EZ System is a temporary intravascular guide wire filtration system that is placed in the vessel distal to the lesion to be treated. It consists of either a polyurethane filter bag 1.5 cm in length or a Bionate (polycarbonate urethane) filter bag, 1.0 cm in length attached near the distal end of a 0.014" silicone coated stainless steel guide wire by means of a collapsible, self-conforming, Nitinol filter loop wire.

Study groups in NCT01133327
Study groupRoleWhat they receive
Adapt Carotid Stent SystemExperimentalIntervention with Adapt Carotid Stent System with the FilterWire EZ System
Receives: Device: Carotid Artery Stenting

What is being measured

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

  1. 30-day rate of major adverse events

    30-day rate of major adverse events, defined as the cumulative incidence of any peri-procedural (less or equal to 30 days postprocedure) death, stroke, or Myocardial Infarction

    Measured: 30-day postprocedure

Secondary outcomes (7)

  1. Late ipsilateral stroke

    Measured: 31 through 365 days post procedure

  2. System Technical Success

    successful placement and retireval of the FilterWire EZ System, and the successful deployment of the Adapt Carotid Stent sytem in the target carotid artery, with a residual stenosis < or equal to 30% as determined by the core lab.

    Measured: the procedure time

  3. Device Malfunctions

    Define as any failure of the device to meet performance specifications or otherwise perform as intended, as defined by the investigator.

    Measured: from index procedure to 365 days post procedure

  4. Serious device-related and procedure-device related Events

    Measured: from index procedure to 365 days post procedure

  5. Target Lesion Revascularization

    any surgical or percutaneous attempt to revascularize the target lesion after the initial or index treatment when the diameter restenosis is either equal to 50% or above with symptoms related to the target lesion or 80% or above without symptoms related to the target lesion.

    Measured: from end of index procedure to 365 days postprocedure

  6. In-stent Restenosis

    Measured: from end of index procedure to 365 days post procedure

  7. Major Adverse Events Rate by subgroups

    Major Adverse Events Rate by subgroups

    • symptomatic and asymptomatic status
    • per center

    Measured: from index procedure to 365 days post procedure

Timeline

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

  1. First posted28 May 2010 (estimated)
  2. Study startJun 2010
  3. Primary completionJun 2011
  4. Study completionJun 2012

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
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
100 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01133327
Sponsor's protocol ID
ASTI
Acronym
ASTI
Status last verified
Aug 2012
First submitted
27 May 2010
Last updated
6 Aug 2012
Results posted
No
Data monitoring committee
No

Publications

  • Coward LJ, Featherstone RL, Brown MM. Safety and efficacy of endovascular treatment of carotid artery stenosis compared with carotid endarterectomy: a Cochrane systematic review of the randomized evidence. Stroke. 2005 Apr;36(4):905-11. doi: 10.1161/01.STR.0000158921.51037.64. Epub 2005 Mar 3.

    PubMed 15746454

  • Nadim Al-Murbarak et al. Carotid Artery Stenting. Lippincott Williams & Wilkins, 2004

  • Hopkins LN, Myla S, Grube E, Wehman JC, Levy EI, Bersin RM, Joye JD, Allocco DJ, Kelley L, Baim DS. Carotid artery revascularization in high surgical risk patients with the NexStent and the Filterwire EX/EZ: 1-year results in the CABERNET trial. Catheter Cardiovasc Interv. 2008 Jun 1;71(7):950-60. doi: 10.1002/ccd.21564.

    PubMed 18412236

  • World Health Report - 2007, from the World Health Organization. Accesses October 31, 2009

  • Stroke Facts and Statistics from the Center of Disease Control and Prevention,Division for Heart Disease and Stroke Prevention. Available at http://www.cdc.gov/Stroke/stroke_facts.htm. Page last modified February 12, 2009. Accessed October 23, 2009.

  • Rosamond W, Flegal K, Furie K, Go A, Greenlund K, Haase N, Hailpern SM, Ho M, Howard V, Kissela B, Kittner S, Lloyd-Jones D, McDermott M, Meigs J, Moy C, Nichol G, O'Donnell C, Roger V, Sorlie P, Steinberger J, Thom T, Wilson M, Hong Y; American Heart Association Statistics Committee and Stroke Statistics Subcommittee. Heart disease and stroke statistics--2008 update: a report from the American Heart Association Statistics Committee and Stroke Statistics Subcommittee. Circulation. 2008 Jan 29;117(4):e25-146. doi: 10.1161/CIRCULATIONAHA.107.187998. Epub 2007 Dec 17. No abstract available.

    PubMed 18086926

  • National Institute of Heath / National Institute of Neurological Disorders and Stroke. NIH Stroke Scale. Available at http://www.ninds.nih.gov/doctors/NIH_Stroke_Scale_Booklet.pdf. Accessed October 23, 2009.

Questions about this trial

What is this clinical trial studying?

A study testing Carotid Artery Stenting in people with Carotid Artery Disease and Carotid Stenosis, run by Boston Scientific Corporation at 11 sites in 3 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 5 inclusion and 13 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 6 Aug 2012. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 11 sites in Germany, Belgium, Spain. 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?

30-day rate of major adverse events (time frame: 30-day postprocedure). 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 NCT01133327, which also lists 7 linked publications.

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 6 Aug 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