UnknownNot Applicable

Study of Drug Eluting Peripheral Vascular Stent System in Superficial Femoral Artery Stenosis and /or Occlusion

China138 participantsStarted 2018-10-22

Plain-language summary

Evaluation of drug eluting peripheral vascular stent system for the treatment of superficial femoral artery stenosis and / or occlusion, there is better in effectiveness and clinical performance compared with similar products already on the market.

Who can participate

Age range

18 Years – 85 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 Preoperative: * Aged from 18 to 85 years old, male or female * Subject's target lesions were stenosis and/or occlusion * Subject is aware of the study content, showing sufficient compliance with the research protocol and sign the Informed Consent Exclusion Criteria in Preoperative: * In-Stent Restenosis(IRS) or restenosis after drug-eluting balloon administration * Serum creatinine concentration of the subject is higher than 1.5 times of the upper limit of normal serum creatinine concentration * Subject with coagulation abnormalities should not be performed

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

primary patency rate at 12 months after operation

Timeframe: 12 months

Trial details

NCT IDNCT03121430

SponsorZhejiang Zylox Medical Device Co., Ltd.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2020-07

Contact for this trial

Gao Feng

+86 (0)10 8220-7036 md@osmundacn.com

View on ClinicalTrials.gov More Peripheral Arterial Disease trials

Who can participate

Age range

18 Years – 85 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.