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 range

18 Years

Sex

ALL

See this in plain English?

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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

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

View on ClinicalTrials.gov More Restenosis trials