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A Multi-Center Study to Evaluate Acute Safety and Clinical Performance of Paladin® Carotid Post-Dilation Balloon System With Integrated Embolic Protection

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02501148
Recruitment Status : Completed
First Posted : July 17, 2015
Last Update Posted : April 4, 2017
Sponsor:
Information provided by (Responsible Party):
Contego Medical, LLC

Brief Summary:
The purpose of this study is to assess the safety and clinical performance of Paladin System in patients with carotid artery stenosis.

Condition or disease Intervention/treatment
Carotid Artery Stenoses Device: carotid artery stenting

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Study Type : Observational [Patient Registry]
Actual Enrollment : 106 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 30 Days
Official Title: A Multi-Center Study to Evaluate Acute Safety and Clinical Performance of Paladin® Carotid Post-Dilation Balloon System With Integrated Embolic Protection
Actual Study Start Date : August 2015
Actual Primary Completion Date : September 2016
Actual Study Completion Date : October 2016

Group/Cohort Intervention/treatment
Carotid artery stenting
Symptomatic and asymptomatic subjects requiring carotid artery stenting, post-dilation performed using the Paladin System with integrated embolic protection
Device: carotid artery stenting
Post-dilation of deployed self-expanding carotid stent with the Paladin Post-Dilation Balloon System with Integrated Embolic Protection
Other Name: Paladin Post-Dilation Balloon System with Integrated Embolic Protection




Primary Outcome Measures :
  1. Device-related MAE [ Time Frame: 30 days ]


Information from the National Library of Medicine

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, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Adults; either gender; requiring percutaneous intervention of an asymptomatic (> 70%) or symptomatic (>50%) internal carotid artery stenosis.
Criteria

Inclusion Criteria:

  • Documented stenotic atherosclerotic lesion located at carotid bifurcation and / or proximal internal carotid artery (ICA)
  • Subject is either (A) symptomatic within 6 months of procedure, with an ipsilateral carotid stenosis ≥ 50% by angiography, or (B) asymptomatic with carotid stenosis ≥ 70% by angiography
  • Target lesion can be covered by a single stent of no more than 40 mm in length
  • Target lesion reference vessel diameter (RVD) is 4.0 mm - 7.0mm
  • Sufficient landing zone required for successful deployment of integrated embolic protection filter
  • Willing to comply with all follow-up required study visits
  • Provision of written informed consent before index procedure

Exclusion Criteria:

  • Life expectancy of less than one year
  • An evolving, acute or recent stroke within 14 days of study evaluation
  • Acute myocardial infarction within 72 hours before procedure
  • Known sensitivity to contrast media that cannot be adequately controlled with pre-medication
  • Subject has a total occlusion of target carotid artery
  • Subject has a previously place stent in ipsilateral carotid artery
  • Severe circumferential lesion calcification that may restrict full deployment of carotid stent
  • Presence of filling defect or thrombus in target vessel
  • Presence of "string sign" of target vessel
  • Carotid (intracranial) stenosis located distal to target lesion
  • Greater than 50% stenosis of common carotid artery proximal to target lesion.
  • Known mobile plaque in aortic arch

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02501148


Locations
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Germany
Universitäts-Herzzentrum Bad Krozingen
Bad Krozingen, Germany, 79189
Sponsors and Collaborators
Contego Medical, LLC
Investigators
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Study Director: Ravish Sachar, MD Contego Medical, LLC
Additional Information:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Contego Medical, LLC
ClinicalTrials.gov Identifier: NCT02501148    
Other Study ID Numbers: CSP-1001
First Posted: July 17, 2015    Key Record Dates
Last Update Posted: April 4, 2017
Last Verified: April 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Contego Medical, LLC:
Embolic protection
Carotid artery stenting
Additional relevant MeSH terms:
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Carotid Stenosis
Carotid Artery Diseases
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases