search
Back to results

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

Primary Purpose

Carotid Stenosis

Status
Unknown status
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Carotid PTA and stenting
Sponsored by
SPSI d.b.a Capital Cardiovascular Associates
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Carotid Stenosis focused on measuring internal carotid artery, common carotid artery, bruit, tia

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Spirit Physycian Services Inc.d.b.a Capital Cardiovascular AssociatesRecruiting

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Single arm

Arm Description

Single arm observational study looking at a "low risk" cohort of individuals with carotid stenosis

Outcomes

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

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

Full Information

First Posted
January 7, 2011
Last Updated
July 30, 2014
Sponsor
SPSI d.b.a Capital Cardiovascular Associates
search

1. Study Identification

Unique Protocol Identification Number
NCT01273350
Brief Title
A Prospective, Non-Randomized, Evaluation of Low-Risk Patients Undergoing Carotid Stenting With ANgiomax (Bivalirudin)
Official Title
Physician I.D.E. G#040160; Low Risk Carotid Stenting Study Using Bivalirudin at PinnacleHealth Hospitals and Holy Spirit Hospital
Study Type
Interventional

2. Study Status

Record Verification Date
July 2014
Overall Recruitment Status
Unknown status
Study Start Date
October 2004 (undefined)
Primary Completion Date
December 2016 (Anticipated)
Study Completion Date
December 2017 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
SPSI d.b.a Capital Cardiovascular Associates

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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
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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Carotid Stenosis
Keywords
internal carotid artery, common carotid artery, bruit, tia

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
154 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Single arm
Arm Type
Other
Arm Description
Single arm observational study looking at a "low risk" cohort of individuals with carotid stenosis
Intervention Type
Device
Intervention Name(s)
Carotid PTA and stenting
Intervention Description
Percutaneous interventional treatment of carotid artery stenosis using XACT carotid artery stent and emboshield protection system with bivalirudin as the procedural anticoagulant
Primary Outcome Measure Information:
Title
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 Measure Information:
Title
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Rajesh M Dave, MD
Phone
717-724-6450
Email
rdintervention@yahoo.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rajesh M Dave, MD
Organizational Affiliation
Spirit Physician Services Inc. d.b.a.Capital Cardiovascular Associates @ PinnacleHealth Hospitals; Holy Spirit Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Spirit Physycian Services Inc.d.b.a Capital Cardiovascular Associates
City
Camp Hill
State/Province
Pennsylvania
ZIP/Postal Code
17011
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Rajesh M Dave, MD
Phone
717-724-6450
Email
rdintervention@yahoo.com
First Name & Middle Initial & Last Name & Degree
Andreas L Wali, MD
Phone
717-724-6450
Email
waliandreas@aol.com
First Name & Middle Initial & Last Name & Degree
Rajesh M Dave, MD,FACC,FSCAI

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs