Recruiting

Angiomax

Sponsor:

SPSI d.b.a Capital Cardiovascular Associates

Code:

NCT01273350

Conditions

Carotid Stenosis

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Carotid PTA and stenting

Study Details

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

Conditions

Carotid Stenosis

Study ID

NCT01273350

Start date

Oct, 2004

Status verified date

Jul, 2014

Completion date

Dec, 2017

Anticipated

Primary completion date

Dec, 2016

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

154 participants

Anticipated

Allocation

Non randomized

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

other: Single arm

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

Interventions

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 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 ]

Central Contacts and Locations

Central contacts

Rajesh M Dave, MD

717-724-6450rdintervention@yahoo.com

Locations

Spirit Physycian Services Inc.d.b.a Capital Cardiovascular Associates

Recruiting

Camp Hill, Pennsylvania, United States, 17011

Contacts

Rajesh M Dave, MD

717-724-6450rdintervention@yahoo.com

Andreas L Wali, MD

717-724-6450waliandreas@aol.com

Principal Investigator:

Rajesh M Dave, MD,FACC,FSCAI

More Information

Sponsor

SPSI d.b.a Capital Cardiovascular Associates

Last update posted

Jul 31, 2014

Last verified

Jul, 2014

Keywords

  • internal carotid artery
  • common carotid artery
  • bruit
  • tia

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by SPSI d.b.a Capital Cardiovascular Associates on 2014-07-31.