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

This study is ongoing, but not recruiting participants.
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
  Purpose

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


Condition
Peripheral Vascular Disease
Embolism and Thrombosis
Venous Thrombosis

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: PEARL II: PEripheral Use of AngioJet® Rheolytic Thrombectomy With a Variety of Catheter Lengths

Resource links provided by NLM:


Further study details as provided by MEDRAD, Inc.:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 500
Study Start Date: January 2010
Estimated Study Completion Date: August 2013
Estimated Primary Completion Date: July 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts
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

Detailed Description:

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.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Community population

Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01086215

  Show 36 Study Locations
Sponsors and Collaborators
MEDRAD, Inc.
Investigators
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
  More Information

No publications provided

Responsible Party: MEDRAD, Inc.
ClinicalTrials.gov Identifier: NCT01086215     History of Changes
Other Study ID Numbers: PEARLII
Study First Received: January 20, 2010
Last Updated: July 9, 2012
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Embolism
Thrombosis
Vascular Diseases
Venous Thrombosis
Venous Thromboembolism
Peripheral Vascular Diseases
Peripheral Arterial Disease
Embolism and Thrombosis
Cardiovascular Diseases
Thromboembolism
Atherosclerosis
Arteriosclerosis
Arterial Occlusive Diseases

ClinicalTrials.gov processed this record on April 21, 2014