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

NCT01264419 | Completed Results

• 1 other identifier: SRM-2008-01
• Study Type: interventional
• Target: 75
• Locations: 1 country
• Sites: 1

Brief Summary

Cerebral embolization during carotid artery stenting (CAS) can often precipitate severe adverse neurological effects. Most major clinical studies of CAS have used distal filters for cerebral protection and have compared the neurologic complication rates with those of carotid endarterectomy (CEA). Many currently available embolic protection devices, however, have limited efficacy in capturing microembolic debris that is liberated during stenting, pre-dilatation and post-dilatation. Distal protection systems are furthermore limited by the need to cross the lesion prior to deployment. Some studies have shown a relatively high incidence of cerebral infarction even when distal protection devices are employed. Cerebral protection with carotid flow reversal is a method that was developed by Parodi, et al., as an alternative to the use of distal protection devices. While novel in its approach, this method too has its limitations. Criado, et al., developed a derivative technique that employs carotid flow reversal prior to traversing the stenosis and can be accomplished by directly accessing carotid anatomy without the use of the transfemoral approach. Major benefits to this method include the ability to perform the procedure on patients with severe carotid tortuosity and difficult aortic arch anatomy.

Conditions

Carotid Artery Diseases

Outcome Measures

Primary Outcomes (1)

• Safety Evaluation as Composite of Occurrences of Major Stroke, Myocardial Infarction and Death

  Safety will be evaluated as a composite of major stroke, myocardial infarction and death during the 30-day post procedural period.

  0 days post-procedure to 30 days post-procedure

Secondary Outcomes (1)

• Number of Participants Demonstrating Acute Device Success, Procedural Success, and Tolerance to Reverse Flow

  peri-operative to 30 days post-procedure

Study Arms (1)

Silk Road Embolic Protection System

EXPERIMENTAL

Eligible subjects who are to receive a carotid artery stent, via transcervical access using reverse flow cerebral protection, as treatment for high-grade extracranial carotid artery disease

Device: Silk Road Embolic Protection System

Interventions

Silk Road Embolic Protection System DEVICE

System that delivers a carotid artery stent, via transcervical access using reverse flow cerebral protection, as treatment for high-grade extracranial carotid artery disease

Silk Road Embolic Protection System

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Silk Road Medical: lead

Study Sites (1)

Augusta-Krankenhaus

Düsseldorf, 40472, Germany

Location

Related Publications (2)

• Pinter L, Ribo M, Loh C, Lane B, Roberts T, Chou TM, Kolvenbach RR. Safety and feasibility of a novel transcervical access neuroprotection system for carotid artery stenting in the PROOF Study. J Vasc Surg. 2011 Nov;54(5):1317-23. doi: 10.1016/j.jvs.2011.04.040. Epub 2011 Jun 12.

  PMID: 21658889 BACKGROUND

• Alpaslan A, Wintermark M, Pinter L, Macdonald S, Ruedy R, Kolvenbach R. Transcarotid Artery Revascularization With Flow Reversal. J Endovasc Ther. 2017 Apr;24(2):265-270. doi: 10.1177/1526602817693607. Epub 2017 Feb 17.

  PMID: 28335706 RESULT

Related Links

• Transcarotid Artery Revascularization With Flow Reversal: The PROOF Study
• Safety and feasibility of a novel transcervical access neuroprotection system for carotid artery stenting in the PROOF Study.

MeSH Terms

Conditions

Carotid Artery Diseases

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Results Point of Contact

• Title: Richard Ruedy, Exec VP Clinical Affairs
• Organization: Silk Road Medical, Inc.

ric@silkroadmed.com

408-828-7281

Study Officials

• Sumaira Macdonald, MD, PhD

  Chief Medical Officer

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

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

Study Record Dates

• First Submitted: December 17, 2010
• First Posted: December 21, 2010
• Study Start: March 1, 2009
• Primary Completion: June 1, 2012
• Study Completion: July 1, 2012
• Last Updated: February 17, 2020
• Results First Posted: July 8, 2019

Record last verified: 2020-01

Locations

DE (1)