UnknownNot Applicable

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

50 participantsStarted 2011-04

Plain-language 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

Who can participate

Age range18 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. Has a Rutherford Clinical Category Score of 1 - 5.
✓. Is willing and capable of complying with all follow-up evaluations at the specified times.
✓. Is ≥ 18 years old.
✓. Provides written informed consent prior to study specific procedures.

Exclusion criteria

✕. Has contraindications listed in any study device IFUs.
✕. Has a contraindication or known untreated allergy to antiplatelet therapy, anticoagulants, thrombolytic drugs or any other drug anticipated to be used.
✕. Has a hypersensitivity to contrast material that cannot be adequately pretreated.
✕. Has known hypersensitivity to treatment device materials including Paclitaxel. Has known uncontrollable hypercoagulable condition, or refuses blood transfusion.

What they're measuring

Target Lesion Percent Stenosis

Timeframe: at 1 Year

Trial details

NCT IDNCT01298947

SponsorHerz-Zentrums Bad Krozingen

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2013-04

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