UnknownPhase 4

Intimal Hyperplasia Evaluated by Optical Coherence Tomography (OCT) in de Novo Coronary Lesions Treated by Drug-eluting Balloon and Bare-metal Stent

Italy30 participantsStarted 2009-11

Plain-language summary

Restenosis due to neointimal hyperplasia causes repeat target vessel revascularization in a relevant number of patients undergoing percutaneous coronary interventions (PCI). Drug-eluting stents (DES) are currently adopted to reduce the rate of restenosis; however, they may increase risk of stent thrombosis. Experimental data and first clinical experiences showed that inhibition of neointimal hyperplasia may be obtained by local administration of anti-proliferative drugs (like paclitaxel) loaded on the surface of angioplasty balloons. Data on the efficacy of novel coronary drug-eluting balloons (DEBs) are lacking. Aims of this open label prospective, randomized trial is to evaluate neointimal hyperplasia in patients undergoing bare-metal stent (BMS) implantation alone compared to those receiving additional DEB use and to assess if the technique of DEB use may affect the degree of neointimal hyperplasia. Neointimal hyperplasia will be assessed by Optical coherence tomography (OCT).

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.

Ages Eligible for Study: 18 Years and older Genders Eligible for Study: Both (female sex with child-bearing potential excluded) Accepts Healthy Volunteers: No Inclusion Criteria: * Non-diabetic patients with a stable coronary artery disease, undergoing elective PCI with BMS * de novo non-complex lesions (no bifurcation lesions, no chronic total occlusions, no severe calcifications, no moderate-to-severe tortuosities) located in straight coronary segments. * lesion length ≥10 mm and \<25 mm. * vessel size requiring a single stent with diameter between 3.0 and 3.5mm. Exclusion Criteria: Clinical: * age \<18 years or impossibility to give informed consent, * diabetes mellitus * female sex with child-bearing potential, * life expectancy less than 6 months or any condition impeding clinical follow-up (no fixed address, etc), * significant platelet count alteration (\<100,000 cells/mm3 or \> 700,000 cells/mm3), * gastrointestinal bleeding requiring surgery or blood transfusions within 4 previous weeks, * participation to another study with any investigational device or drug within which is still in the active phase. * history of clotting pathology, known hypersensitivity to aspirin, heparin, cobalt- chromium, paclitaxel, contrast dye, * renal failure with creatinine value \> 2.5 mg/dl, * poor cardiac function as defined by left ventricular global ejection fraction ≤ 30% * acute myocardial infarction within the past 48 hours. * non ST-elevation acute coronary syndrome Angiogra…

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 Endpoint: Neo-intimal area (mm²).

Timeframe: 6 months post procedure

Trial details

NCT IDNCT01057563

SponsorCatholic University of the Sacred Heart

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2010-11

Contact for this trial

Francesco Burzotta, MD, PhD

39-349-4295290 f.burzotta@rm.unicatt.it

View on ClinicalTrials.gov More Coronary Artery Disease trials