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

This study is currently recruiting participants.
Verified July 2013 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 29, 2013
Last verified: July 2013

January 7, 2011
July 29, 2013
October 2004
December 2014   (final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT01273350 on ClinicalTrials.gov Archive Site
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 ]
Same as current
Not Provided
Not Provided
 
A Prospective, Non-Randomized, Evaluation of Low-Risk Patients Undergoing Carotid Stenting With ANgiomax (Bivalirudin)
Physician I.D.E. G#040160; Low Risk Carotid Stenting Study Using Bivalirudin at PinnacleHealth Hospitals and Holy Spirit Hospital

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

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

Interventional
Not Provided
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
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
Single arm
Single arm observational study looking at a "low risk" cohort of individuals with carotid stenosis
Intervention: Device: Carotid PTA and stenting
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
154
December 2014
December 2014   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact: Rajesh M Dave, MD 717-724-6450 rdintervention@yahoo.com
United States
 
NCT01273350
Physician IDE G # 040160
Yes
Rajesh Dave, MD, SPSI d.b.a Capital Cardiovascular Associates
SPSI d.b.a Capital Cardiovascular Associates
Not Provided
Principal Investigator: Rajesh M Dave, MD Spirit Physician Services Inc. d.b.a.Capital Cardiovascular Associates @ PinnacleHealth Hospitals; Holy Spirit Hospital
SPSI d.b.a Capital Cardiovascular Associates
July 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP