Trial record 1 of 1 for:    NCT01273350
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A Prospective, Non-Randomized, Evaluation of Low-Risk Patients Undergoing Carotid Stenting With ANgiomax (Bivalirudin)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01273350
Recruitment Status : Unknown
Verified July 2014 by Rajesh Dave, MD, SPSI d.b.a Capital Cardiovascular Associates.
Recruitment status was:  Recruiting
First Posted : January 10, 2011
Last Update Posted : July 31, 2014
Information provided by (Responsible Party):
Rajesh Dave, MD, SPSI d.b.a Capital Cardiovascular Associates

Brief Summary:
Prospective, non-randomized, single-center cohort study treating internal carotid artery stenosis using the Xact Carotid Artery Stent and emboshield distal protection system in conjunction with bivalirudin as the procedural anticoagulation

Condition or disease Intervention/treatment Phase
Carotid Stenosis Device: Carotid PTA and stenting Not Applicable

Detailed Description:

Primary objective is to evaluate the safety and feasibility of the XACT stent and emboshield with Angiomax as the procedural anticoagulant.

Primary safety endpoint is the occurrence of Major Adverse Events, defined as death, myocardial infarction (Q or non Q wave), and from target revascularization at one year

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 154 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Physician I.D.E. G#040160; Low Risk Carotid Stenting Study Using Bivalirudin at PinnacleHealth Hospitals and Holy Spirit Hospital
Study Start Date : October 2004
Estimated Primary Completion Date : December 2016
Estimated Study Completion Date : December 2017

Resource links provided by the National Library of Medicine

Drug Information available for: Bivalirudin

Arm Intervention/treatment
Single arm
Single arm observational study looking at a "low risk" cohort of individuals with carotid stenosis
Device: Carotid PTA and stenting
Percutaneous interventional treatment of carotid artery stenosis using XACT carotid artery stent and emboshield protection system with bivalirudin as the procedural anticoagulant

Primary Outcome Measures :
  1. Major adverse events, defined as death, ipsilateral stroke, myocardial infarction,(Q and non-Q wave) or major bleeding as 30 days post procedure [ Time Frame: 30 days ]

Secondary Outcome Measures :
  1. Freedom from vascular complications ;Acute success defined by lesion, device, and procedural success; Freedom from any death, stroke MI (Q, non-Q wave), and from target lesion revascularization at one year [ Time Frame: 1 Year ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Patient (male or non-pregnant female)must be > than or= 18
  • Qualifying non-invasive test (ultrasound or MRA) was performed less than 60 days prior to study entry. Carotid duplex study revealed:

    • Stenosis > or = to 50% in symptomatic patients
    • Stenosis > or = to 60% in asymptomatic patients
  • Target lesion may be in the common or internal carotid artery and is amenable to treatment with angioplasty and stenting
  • Patients taking warfarin may be included if their dosage is reduced before the procedure to result in an INR of 1.5 or less and a Prothrombin time of 15 seconds. Warfarin may be started after the procedure.
  • Female patients of childbearing potential must have a documented negative pregnancy test during index hospitalization
  • Patient or legally authorized representative must sign a written informed consent, prior to the procedure, using a form that is approved by the local institutional review board or medical ethics committee

Exclusion Criteria: (Patients will be excluded from the study if ANY of the following conditions are present)

  • There is total occlusion of the target carotid artery treatment site.
  • The patient has an allergy or contraindication to aspirin, ticlopidine, clopidogrel, bivalirudin, nickel, titanium, or a sensitivity to contrast media, which cannot adequately pre-medicated.
  • The subject has a platlet count< 100,000 cells/mm3 or 700,000 cells/mm3 or a WBC of < 3,000 cells/mm3.
  • Stroke within 7 days prior to the procedure
  • NIH stroke score > or = to 15 within 7 days prior to the procedure
  • The patient has experienced a significant GI bleed within 6 months prior to study procedure
  • The patient has active internal bleeding
  • The patient has had major surgery or serious trauma within 6 weeks before enrollment
  • The patient has excessive peripheral vascular disease that precludes safe sheath insertion
  • The patient has had an intracranial hemorrhage, hemorrhagic stroke, major stroke or any stroke within one week of index procedure
  • The patient has concurrent emboligenic cardiovascular disease not adequately treated with anticoagulant therapy
  • The patient is on renal dialysis
  • The patient has had low molecular weight heparin (LMWH) administered within 8 hours or less, prior to the procedure
  • Severe hypertension not adequately controlled by antihypertensive therapy at the time of study entry(BP> 180/110mmHG)
  • The patient is unable or unwilling to cooperate with the study follow-up procedures

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01273350

Contact: Rajesh M Dave, MD 717-724-6450

United States, Pennsylvania
Spirit Physycian Services Inc.d.b.a Capital Cardiovascular Associates Recruiting
Camp Hill, Pennsylvania, United States, 17011
Contact: Rajesh M Dave, MD    717-724-6450   
Contact: Andreas L Wali, MD    717-724-6450   
Principal Investigator: Rajesh M Dave, MD,FACC,FSCAI         
Sponsors and Collaborators
SPSI d.b.a Capital Cardiovascular Associates
Principal Investigator: Rajesh M Dave, MD Spirit Physician Services Inc. d.b.a.Capital Cardiovascular Associates @ PinnacleHealth Hospitals; Holy Spirit Hospital

Responsible Party: Rajesh Dave, MD, Chief Medical Executive Holy Spirit Cardiovascular Institute, SPSI d.b.a Capital Cardiovascular Associates Identifier: NCT01273350     History of Changes
Other Study ID Numbers: Physician IDE G # 040160
First Posted: January 10, 2011    Key Record Dates
Last Update Posted: July 31, 2014
Last Verified: July 2014

Keywords provided by Rajesh Dave, MD, SPSI d.b.a Capital Cardiovascular Associates:
internal carotid artery
common carotid artery

Additional relevant MeSH terms:
Carotid Stenosis
Carotid Artery Diseases
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases
Serine Proteinase Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action