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

Boston Scientific

Status: Completed

Conditions: Peripheral Vascular Disease; Embolism and Thrombosis; Venous Thrombosis

Study type: Observational

Funder types: Industry

Identifiers

NCT01086215

PEARLII

Details and patient eligibility

About

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

Full 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.

Enrollment: 500 patients

Sex: All

Volunteers: No Healthy Volunteers

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.

Trial design

500 participants in 4 patient groups

Limb Ischemia

Description:

Patients presenting with limb ischemia for treatment

Deep Vein Thrombosis

Description:

Patients presenting with deep vein thrombosis for treatment

Hemodialysis Access

Description:

Patients presenting with thrombosed hemodialysis access for treatment

Other Thrombotic Conditions

Description:

Patients presenting with a thrombotic condition other than limb ischemia, deep vein thrombosis or thrombosed hemodialysis access for treatment