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A Prospective, Non-Randomized, Evaluation of Low-Risk Patients Undergoing Carotid Stenting With ANgiomax (Bivalirudin)

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2014 by SPSI d.b.a Capital Cardiovascular Associates
Sponsor:
Information provided by (Responsible Party):
Rajesh Dave, MD, SPSI d.b.a Capital Cardiovascular Associates
ClinicalTrials.gov Identifier:
NCT01273350
First received: January 7, 2011
Last updated: July 30, 2014
Last verified: July 2014
  Purpose

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 Intervention
Carotid Stenosis
Device: Carotid PTA and stenting

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by SPSI d.b.a Capital Cardiovascular Associates:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 154
Study Start Date: October 2004
Estimated Study Completion Date: December 2017
Estimated Primary Completion Date: December 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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

  Eligibility

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

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
  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: NCT01273350

Contacts
Contact: Rajesh M Dave, MD 717-724-6450 rdintervention@yahoo.com

Locations
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    rdintervention@yahoo.com   
Contact: Andreas L Wali, MD    717-724-6450    waliandreas@aol.com   
Principal Investigator: Rajesh M Dave, MD,FACC,FSCAI         
Sponsors and Collaborators
SPSI d.b.a Capital Cardiovascular Associates
Investigators
Principal Investigator: Rajesh M Dave, MD Spirit Physician Services Inc. d.b.a.Capital Cardiovascular Associates @ PinnacleHealth Hospitals; Holy Spirit Hospital
  More Information

No publications provided

Responsible Party: Rajesh Dave, MD, Chief Medical Executive Holy Spirit Cardiovascular Institute, SPSI d.b.a Capital Cardiovascular Associates
ClinicalTrials.gov Identifier: NCT01273350     History of Changes
Other Study ID Numbers: Physician IDE G # 040160
Study First Received: January 7, 2011
Last Updated: July 30, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by SPSI d.b.a Capital Cardiovascular Associates:
internal carotid artery
common carotid artery
bruit
tia

Additional relevant MeSH terms:
Carotid Stenosis
Arterial Occlusive Diseases
Brain Diseases
Cardiovascular Diseases
Carotid Artery Diseases
Central Nervous System Diseases
Cerebrovascular Disorders
Nervous System Diseases
Vascular Diseases
Bivalirudin
Anticoagulants
Antithrombins
Enzyme Inhibitors
Hematologic Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Protease Inhibitors
Serine Proteinase Inhibitors
Therapeutic Uses

ClinicalTrials.gov processed this record on November 24, 2014