Clinical Trials Logo

Clinical Trial Summary

The purpose of the registry is to gather both retrospective and prospective case data on the use of the commercially available Magellan Robotic System and Magellan Robotic Catheters in accordance with the approved intended use. For prospective cases, follow-up patient data will be collected at 14 days (± 5 days) post procedure to assess treatment success, primary patency of intended targeted vessel region, and adverse events.

The data will be analyzed for medical education, societal presentation, and/or publication by the investigators.

Over the next 2+ years, physicians who meet the selection criteria will be invited to participate in the registry.


Clinical Trial Description

The objectives of the study are to allow the physician to use the commercially available Magellan Robotic System and Magellan Robotic Catheters to navigate to the treatment targets in the peripheral vasculature to:

- Determine the number of endovascular procedures consecutively performed with the Magellan Robotic System to navigate to treatment targets in the peripheral vasculature and,

- Achieve stable and efficient system preparation and set-up times, navigation and cannulation times of target vessels during endovascular procedures, and placement of therapeutic equipment used to perform endovascular procedures.

- Achieve stable and reduced fluoroscopy time during the endovascular procedures.

- Determine the number of cases required to reach a "steady state," reduction or predictable time in conducting peripheral interventional procedures using descriptive (means, ranges) statistics to analyze the data.

Design

This is a prospective and retrospective, multi-center, single arm, non-blinded, sequentially enrolling data collection activity (for which Hansen Medical is providing funding). Only patients scheduled to undergo endovascular procedures using the Magellan Robotic System will be approached for enrollment.

Methods

Registry procedures will be conducted in accordance with the labeled indication for use of the Magellan™ Robotic System.

Prior to the physician participating in the registry and prior to subject enrollment, all participating physicians will be required to complete Hansen Medical's Magellan Robotic System training.

Participating registry sites must have a commercially available Magellan Robotic System for the treatment of patients.

Data Management

Participating sites will be assigned a specific site numeric identification code by the registry sponsor.

The information collected into the registry will be data related to the procedure in which the Magellan System was used or planned to be used and may include patient follow-up data, minimally 14 days(± 5 days)post procedure but also may include 30 day follow-up to assess for the resolution of a procedural or post procedure adverse event.

The database will be a repository for the collected registry data and the data will be made available (in extractable format) to the physician participants.

Adverse Events

The data submitted will be reviewed on a regular basis for safety issues and complaints.

Adverse events and/or complaints deemed reportable will be submitted to the appropriate regulatory agency/agencies by Hansen Medical, Inc. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT01984437
Study type Observational [Patient Registry]
Source Hansen Medical
Contact
Status Terminated
Phase N/A
Start date November 2013
Completion date August 2016

See also
  Status Clinical Trial Phase
Recruiting NCT05335525 - Post-market Clinical Investigation of the Angio-Seal™ VIP VCD (ANGIO-SEAL CLOSE)
Active, not recruiting NCT01903044 - Safety and Efficacy of Autologous Bone Marrow Stem Cells for Lower Extremity Ischemia Treating Phase 1/Phase 2
Completed NCT02271529 - Zilver PTX Delivery System N/A
Completed NCT02228564 - BARD® Study of LIFESTREAM™ Balloon Expandable Covered Stent Treating Iliac Arterial Occlusive Disease N/A
Recruiting NCT02054871 - RCT to Evaluate the Renal Protective Effects of Remote Ischaemic Preconditioning in Peripheral Angioplasty N/A
Completed NCT00822172 - Evaluation of Cilostazol in Combination With L-Carnitine Phase 4
Completed NCT00574782 - Evaluation of the Efficacy of Rosuvastatin in Daily Practice in Untreated High Risk Patients (CHALLENGE) N/A
Completed NCT00029991 - Extract of Ginkgo Biloba (EGB 761) and Vascular Function Phase 1/Phase 2
Completed NCT01355406 - Evaluation of Safety and Efficacy of the FlexStent® Femoropopliteal Self-Expanding Stent System N/A
Recruiting NCT05804097 - Does Increasing Oxygen Nurture Your Symptomatic Ischemic Ulcer Sufficiently? Phase 4
Recruiting NCT03638115 - The VaSecure BTK Study N/A
Active, not recruiting NCT03241459 - Safety and Efficacy of the SurVeil™ Drug-Coated Balloon N/A
Active, not recruiting NCT01661231 - Study to Determine the Performance of the Astron and Pulsar-18 Stents in Europe N/A
Completed NCT01722877 - JetStream (JS) Atherectomy in Femoropopliteal In-Stent Restenotic Lesions N/A
Completed NCT01444378 - Absolute Pro® MOMENTUM™ N/A
Completed NCT00753337 - The ACTIVE (Use of the Assurant® Cobalt Iliac Stent System in the Treatment of Iliac Vessel Disease) Study N/A
Completed NCT00593385 - Atrium iCAST Iliac Stent Pivotal Study N/A
Completed NCT00538226 - Evaluation of the Effect of the Flowaid Device in Increasing Local Circulation in the Leg Phase 1
Recruiting NCT00385385 - RESTORE-IT-Study of Rifalazil in Chlamydia Pneumoniae Seropositive Patients With a History of Atherosclerotic Disease Phase 2
Completed NCT00392509 - ALD-301 for Critical Limb Ischemia, Randomized Trial Phase 1/Phase 2