UnknownPhase 2/3

Cotavance™ Paclitaxel-Coated Balloon Versus Uncoated Balloon Angioplasty for Treatment of In-stent Restenosis in SFA and Popliteal Arteries

Germany112 participantsStarted 2012-01

Plain-language summary

In stent restenosis in peripheral artery disease (superficial and popliteal artery) either treated with uncoated or paclitaxel coated balloons.

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

. In-stent restenosis or re-occlusion at the target lesion due to an interventional treatment \> 3 months prior to enrollment.
. Has evidence of ≥ 70% stenosis or occlusion in the SFA and/or popliteal confirmed by angiography that is 3-27 cm long.
. Reference vessel diameter of 3 to 7 mm (reference vessel diameter = normal vessel diameter 1 cm proximal of the index lesion)
. Patients (men and women) with PAD disease category 2 to 5 according to Rutherford classification.
. Patient is eligible for an operative vascular intervention in case of complications during the procedure.
. Female patients of child bearing potential must have a negative pregnancy test 7 days at theprior to the time of intervention.
. Fully informed and signed consent must be obtained from each patient.
. Patients must be willing and able to continue study participation following study procedure in order to ensure completion of all procedures and observations required by protocol.

Exclusion criteria

. Patients with more than two lesions in the target vessel requiring treatment (if the distance between two lesions is less than 2 cm, the lesions should be counted as one lesion). The second lesion should also be treated with either coated or uncoated balloons (according to the randomization)

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

Late Lumen Loss (LLL)

Timeframe: 6 +/-2 months

Trial details

NCT IDNCT01594684

SponsorProf. Dr. med. Gunnar Tepe

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2014-01

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