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Silk Road Medical First in Man Study - Neuroprotection During Carotid Stenting and Angioplasty

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Silk Road Medical
ClinicalTrials.gov Identifier:
NCT01264419
First received: December 17, 2010
Last updated: March 16, 2017
Last verified: March 2017
  Purpose
The purpose of this study is to demonstrate the safety and feasibility of the Silk Road Medical Embolic Protection System for use in subjects who are candidates for Carotid Artery Stenting (CAS). Safety is a composite of any major stroke, myocardial infarction and death during the 30-day post procedural period.

Condition Intervention Phase
Carotid Artery Diseases
Device: Carotid angioplasty and stenting with Silk Road Embolic Protection System
Phase 3

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: No masking
Primary Purpose: Treatment

Resource links provided by NLM:


Further study details as provided by Silk Road Medical:

Primary Outcome Measures:
  • Perioperative Major Adverse Events (stroke, death, MI) through 30 days [ Time Frame: 30 days ]

Secondary Outcome Measures:
  • Assessment of new brain lesions by diffusion weighted magnetic resonance imaging (DW-MRI) [ Time Frame: post-operative up to discharge ]

Enrollment: 75
Study Start Date: March 2009
Study Completion Date: July 2012
Primary Completion Date: June 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Single Device: Carotid angioplasty and stenting with Silk Road Embolic Protection System
Major Adverse Event (MAE) rate with reverse flow neuroprotection
Other Name: Silk Road Embolic Protection System

  Eligibility

Ages Eligible for Study:   21 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Subject must be > 21 years of age.
  • Subject has the ability to understand and cooperate with study procedures and agrees to return for all required follow-up visits, tests and exams.
  • Subjects taking warfarin may be included if their dosage is reduced before the procedure to result in an International Normalized Ratio (INR) of 1.5 or less. Warfarin may be restarted to therapeutic dose after the procedure.
  • The subject must sign a written informed consent prior to the procedure, using a form that is approved by the local medical ethics committee (EC).
  • The life expectancy of the subject is at least one year.
  • The subject has a lesion located in the internal carotid artery (ICA); the carotid bifurcation may be involved.
  • The subject must have a minimum distance of 5 cm between the clavicle and bifurcation, as assessed by duplex Doppler ultrasound, computed axial tomographic (CT) angiography or magnetic resonance (MR) angiography.

Exclusion Criteria:

  • The subject was participating in another investigational trial that would interfere with the conduct or result of this study.
  • The subject had dementia or a neurological illness that may confound the neurological evaluation.
  • Presence of any one of the following anatomic risk factors:

    • Previous radiation treatment to the neck or radical neck dissection
    • Tracheostomy or tracheal stoma
    • Laryngectomy
    • Contralateral laryngeal nerve palsy
    • Severe tandem lesions
    • Inability to extend the head due to cervical arthritis or other cervical disorders
  • A total occlusion of the target vessel.
  • There was an existing, previously placed stent in the target artery.
  • The subject had a known life-threatening allergy to the contrast media that cannot be treated.
  • Subject had history of intolerance or allergic reaction to any of the study medications including aspirin, Clopidogrel bisulfate (Plavix®) or Ticlopidine (Ticlid®), heparin or Bivalrudin (Angiomax™). Subject was unable to tolerate a combination of aspirin and Clopidogrel/Ticlopidine.
  • The subject had a GI bleed that would interfere with antiplatelet therapy.
  • The subject had known cardiac source of potential emboli.
  • Subject had a Hemoglobin (Hgb) level less than 8 gm/dL (unless on dialysis), platelet count < 50,000/mm3, or known heparin associated thrombocytopenia.
  • Subject had documented atrial fibrillation in the 90 days prior to the procedure.
  • The subject had a history of bleeding diathesis or coagulopathy including thrombocytopenia or an inability to receive heparin in amounts sufficient to maintain an Activated Clot Time (ACT) at > 250, or will refuse blood transfusion.
  • The subject had atherosclerotic disease involving in the ipsilateral common carotid artery that precluded safe placement of the arterial sheath.
  • The subject has other abnormal angiographic findings that indicate the subject is at risk for a stroke due to a problem other than that of the target lesion, such as: ipsilateral arterial stenosis greater in severity than the target lesion, cerebral aneurysm, or arteriovenous malformation of the cerebral vasculature.
  • There is evidence of a carotid artery dissection prior to the initiation of the procedure.
  • There is an angiographically visible thrombus.
  • There is any condition that precludes proper angiographic assessment or makes percutaneous arterial access unsafe, e.g. morbid obesity, sustained systolic blood pressure > 180 mm Hg, tortuosity, occlusive disease, vessel anatomy, aortic arch anatomy, or cerebral protective system.
  • Occlusion (TIMI 0 flow), or string sign of the ipsilateral common or internal carotid artery.
  • There is evidence of bilateral carotid stenosis that would require intervention within 30 days of procedure.
  • There is evidence of a stroke within the previous 30 days of the procedure.
  • There is a planned treatment of a non-target lesion within 30 days post procedure.
  • There is a history of intracranial hemorrhage within the previous 3 months, including hemorrhagic transformation of an ischemic stroke.
  • There is a history of an ipsilateral stroke with fluctuating neurologic symptoms within one year of the procedure.
  • Female subjects who are pregnant or may become pregnant.
  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: NCT01264419

Locations
Germany
Augusta-Krankenhaus
Dusseldorf, Germany, 40472
Sponsors and Collaborators
Silk Road Medical
  More Information

Additional Information:
Publications:
Responsible Party: Silk Road Medical
ClinicalTrials.gov Identifier: NCT01264419     History of Changes
Other Study ID Numbers: SRM-2008-01
Study First Received: December 17, 2010
Last Updated: March 16, 2017

Additional relevant MeSH terms:
Carotid Artery Diseases
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on May 25, 2017