Carotid Artery Stenting With Emboli Protection Surveillance-Post-Marketing Study (CASES-PMS)

This study has been completed.
Sponsor:
Information provided by:
Cordis Corporation
ClinicalTrials.gov Identifier:
NCT00231231
First received: September 30, 2005
Last updated: July 19, 2007
Last verified: July 2007
  Purpose

The primary objective of this study is to assess the outcomes of stenting with distal protection in the treatment of obstructive carotid artery disease during peri-approval/initial commercialization in relation to the outcomes of the Sapphire Clinical Trial. The devices to be utilized are the Cordis PRECISE Nitinol Stent Systems and the Cordis ANGIOGUARD™ XP Emboli Capture Guidewire (ECGW).


Condition Intervention Phase
Carotid Artery Disease
Device: -PRECISE Nitinol Stent System (5F, 5.5F and 6F)
Device: ANGIOGUARD™ XP Emboli Capture Guidewire (ECGW)
Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Carotid Artery Stenting With Emboli Protection Surveillance-Post-Marketing Study (CASES-PMS)

Resource links provided by NLM:


Further study details as provided by Cordis Corporation:

Primary Outcome Measures:
  • The primary endpoint of this study is a 30-day composite of major adverse clinical events (MAE) including any death, myocardial infarction, or stroke. [ Time Frame: 30 day ]

Estimated Enrollment: 1500
Study Start Date: September 2004
Study Completion Date: November 2006
  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. The patient must be > 18 years of age.
  2. The patient has a 50% stenosis (as determined by ultrasound or angiogram) of the common or internal carotid artery and is clinically symptomatic; i.e., within the previous 180 days has experienced symptoms in the ipsilateral carotid artery distribution, defined as:

    • one or more TIAs, characterized by distinct focal neurologic dysfunction or monocular blindness with clearing of signs and symptoms within 24 hours, or
    • one or more completed strokes (as defined by this protocol) with persistence of symptoms or signs for more than 24 hours (the most recent event is used as the qualifying event), except as excluded below, with stenosis >50%, (as determined by ultrasound or angiogram) of the common or internal carotid artery, OR The patient must have a >80% diameter stenosis (as determined by ultrasound or angiogram) of the internal or common carotid artery without neurological symptoms.
  3. To be entered into the study, the patient must have one or more of the following conditions:

    · congestive heart failure (class III/IV) and/or known severe left ventricular dysfunction LVEF < 30%

    • open heart surgery within six weeks
    • recent MI (>24 hours and <4 weeks)
    • unstable angina (CCS class III/IV)
    • synchronous severe cardiac and carotid disease requiring open heart surgery and carotid revascularization
    • severe pulmonary disease to include any of the following:
  1. chronic oxygen therapy
  2. resting PO2 of 60 mmHg
  3. baseline hematocrit 50%
  4. FEV1 or DLCO 50% of normal. · contralateral carotid occlusion · contralateral laryngeal palsy · post-radiation treatment · previous CEA recurrent stenosis · high cervical ICA lesions · CCA lesions below the clavicle · severe tandem lesions

    • abnormal stress test.

4. The qualifying ultrasound or angiogram was performed less than 30 days prior to study entry.

· Stenosis >50%: PSV>130 cm/sec; EDV <135 cm/sec

· Stenosis >80%: PSV>220 cm/sec; EDV <135 cm/sec

· PSV ICA/PSV CCA ratio 4.0

5. The target vessel is in the native common or internal carotid artery. The arterial segment to be treated has a diameter between 4 mm and 9 mm as the largest diameter either proximal or distal to the lesion.

Exclusion Criteria:

  1. The patient is experiencing an acute ischemic neurologic stroke or has experienced a stroke within the past 48 hours.
  2. There is any visual angiographic or ultrasound evidence of intraluminal thrombus thought to increase the risk of plaque fragmentation and distal embolization.
  3. There is total occlusion of the target carotid artery treatment site.
  4. The reference segment diameter (distal common carotid and internal carotid artery segment cephalic to the lesion) is less than 4mm or greater than 9mm. See Instructions For Use, for proper stent sizing. The exception to this would be with a lesion having >95% stenosis where the true diameter of the distal vessel cannot be determined such as the case with a string sign or distal vessel collapse. In this case the judgment of the interventionalist will prevail with the intention not to oversize the stent to the distal vessel by more than 2mm.
  5. The patient has any intracranial aneurysm (> 9 mm).
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00231231

Locations
United States, Ohio
Cleveland Clinic
Cleveland, Ohio, United States, 44195
Sponsors and Collaborators
Cordis Corporation
Investigators
Study Director: Sidney A. Cohen, MD, PhD Cordis Corporation
  More Information

Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00231231     History of Changes
Other Study ID Numbers: P04-5204
Study First Received: September 30, 2005
Last Updated: July 19, 2007
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Carotid Artery Diseases
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on April 23, 2014