Trial record 2 of 48 for:    PEARL II

Registry of AngioJet Use in the Peripheral Vascular System (PEARLII)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2012 by MEDRAD, Inc..
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by (Responsible Party):
MEDRAD, Inc.
ClinicalTrials.gov Identifier:
NCT01086215
First received: January 20, 2010
Last updated: July 9, 2012
Last verified: July 2012

January 20, 2010
July 9, 2012
January 2010
July 2013   (final data collection date for primary outcome measure)
  • To estimate the rate of AngioJet® System related adverse events. [ Time Frame: Day 1, 3 Month , 6 Month and 12 Month Follow Ups ] [ Designated as safety issue: Yes ]
  • To estimate the change in degree of occlusion from Baseline to Final angiogram. [ Time Frame: Day 1 ] [ Designated as safety issue: No ]
  • To estimate the proportion of successful patients post-procedure and those affected by restenosis and /or rethrombosis of the treated vessels throughout a 12 Month Follow-Up. [ Time Frame: Day 1, 3 Month , 6 Month and 12 Month Follow Ups ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01086215 on ClinicalTrials.gov Archive Site
  • To characterize treatment options used concomitantly with the AngioJet® System for occlusions occurring in the peripheral vascular system. [ Time Frame: Day 1 ] [ Designated as safety issue: No ]
  • To characterize the occurrence of clinical events. [ Time Frame: Day 1, 3 Month , 6 Month and 12 Month Follow Ups ] [ Designated as safety issue: Yes ]
  • To estimate the proportion of limb ischemia patients in whom the limb was salvaged. [ Time Frame: Day 1, 3 Month , 6 Month and 12 Month Follow Ups ] [ Designated as safety issue: No ]
  • To assess the quality of life at Baseline and throughout a 12 Month Follow-Up. [ Time Frame: Day 1, 3 Month , 6 Month and 12 Month Follow Ups ] [ Designated as safety issue: No ]
  • To estimate the compressibility and valve closure time in lower extremity DVT patients. [ Time Frame: Day 1, 3 Month , 6 Month and 12 Month Follow Ups ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Registry of AngioJet Use in the Peripheral Vascular System
PEARL II: PEripheral Use of AngioJet® Rheolytic Thrombectomy With a Variety of Catheter Lengths

The Registry involves the collection of information for research and educational purposes only on the use of AngioJet in the peripheral vascular system.

The PEARL II Registry is a prospective, multi-center, observational registry including 500 patients who meet eligibility from up to 50 sites worldwide. Patient participation will be 12 months including post procedure follow-up contact at 3, 6 and 12 months. The study duration is estimated at 36 months.

A patient's treatment is determined by the treating physician based on the clinical situation and local practices. In contrast to a randomized, controlled trial, there are no pre-defined experimental interventions.

Observational
Observational Model: Case-Only
Time Perspective: Prospective
Not Provided
Not Provided
Non-Probability Sample

Community population

  • Peripheral Vascular Disease
  • Embolism and Thrombosis
  • Venous Thrombosis
Not Provided
  • Limb Ischemia
    Patients presenting with limb ischemia for treatment
  • Deep Vein Thrombosis
    Patients presenting with deep vein thrombosis for treatment
  • Hemodialysis Access
    Patients presenting with thrombosed hemodialysis access for treatment
  • Other Thrombotic Conditions
    Patients presenting with a thrombotic condition other than limb ischemia, deep vein thrombosis or thrombosed hemodialysis access for treatment
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
500
August 2013
July 2013   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Patient has been treated in the peripheral vascular system with any of the AngioJet System catheters.
  • Patient has provided appropriate consent/authorization per the site's institutional policy and procedure.

Exclusion Criteria:

  • Patient has previously been enrolled in either the PEARL Registry or the PEARL II Registry in the last 12months.
Both
Not Provided
No
Contact information is only displayed when the study is recruiting subjects
United States,   Canada,   Germany,   Italy,   Slovakia
 
NCT01086215
PEARLII
No
MEDRAD, Inc.
MEDRAD, Inc.
Not Provided
Principal Investigator: Lawrence Blitz, MD Chilton Memorial Hospital
Study Director: Robert Lookstein, MD Mount Sinai School of Medicine
Principal Investigator: Ali Amin, MD The Reading Hospital & Medical Center
MEDRAD, Inc.
July 2012

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