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Photoablative Atherectomy Followed by a Paclitaxel-Coated Balloon to Inhibit Restenosis in Instent Femoro-popliteal Obstructions

NCT01298947 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2011-02-21

No results posted yet for this study

Summary

The objective of this study is to evaluate the safety and efficacy of preparing a vessel with photoablation with Spectranetics CVX-300® Excimer laser and laser catheters prior to local Paclitaxel delivery compared to local Paclitaxel delivery without initial photoablation

Conditions

  • Restenosis

Interventions

DEVICE

Laser Atherectomy (Spectranetics CE marked peripheral laser atherectomy catheters (including Turbo Elite®), Turbo-Booster® and Turbo Tandem™ Systems

comparing the use of a Paclitaxel-eluting angioplasty balloon (PTX PTA) with initial photoablation to the use of PTX PTA alone in the treatment of instent lesions in femoropopliteal arteries

Sponsors & Collaborators

  • Herz-Zentrums Bad Krozingen

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-04-30
Primary Completion
2013-04-30
Completion
2013-04-30

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01298947 on ClinicalTrials.gov