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New treatment option for Coronary Angioplasty
Official title Optimal Strategy to Correct Stent underexpAnsion in Resistant Lesions
ClinicalTrials.gov ID: NCT07316504
What this study is testing
- What it's testing
- Percutaneous coronary intervention (PCI) for in-stent restenosis (ISR) accounts for 5-10% of PCI. ISR may be linked to mechanical complications mainly under-expansion (UE), neointimal hyperplasia and/or neoatherosclerosis.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Patient who have undergone coronary angiography with ISR, defined as ≥50% reduction of the diameter of the intrastent lumen occurring ≥ 6 months...
- And with a suspicion of stent under-expansion on angiography, possibly assisted by a stent enhancement technique
- The reference diameter of the target vessel must be ≥2.5 mm and ≤5.0 mm.
- Coronary flow must be TIMI 3
- Ability to cross the lesion with the OCT catheter (possibly after predilatation with a balloon up to 2 mm)
You likely can't join if
- Heart failure with NYHA III or IV (or cardiogenic shock)
- LVEF \<20%
- Chronic renal failure with clearance \<30mL/mn according to CKD
- Pregnant or breast-feeding women
- Patient with a condition/comorbidity that could reduce compliance with the protocol, including pre-specified study follow-up
- Patient participating in another ongoing medical study evaluating a pharmacological or biological agent or medical device, unless authorized by the...
See the full eligibility criteria
- Patient who have undergone coronary angiography with ISR, defined as ≥50% reduction of the diameter of the intrastent lumen occurring ≥ 6 months after stent implantation
- And with a suspicion of stent under-expansion on angiography, possibly assisted by a stent enhancement technique
- The reference diameter of the target vessel must be ≥2.5 mm and ≤5.0 mm.
- Coronary flow must be TIMI 3
- Ability to cross the lesion with the OCT catheter (possibly after predilatation with a balloon up to 2 mm)
- Patient affiliated to the French National Health Insurance
- Heart failure with NYHA III or IV (or cardiogenic shock)
- LVEF \<20%
- Chronic renal failure with clearance \<30mL/mn according to CKD
- Pregnant or breast-feeding women
- Patient with a condition/comorbidity that could reduce compliance with the protocol, including pre-specified study follow-up
- Patient participating in another ongoing medical study evaluating a pharmacological or biological agent or medical device, unless authorized by the concomitant protocol.
- Patient unable to tolerate double antiaggregation (i.e., aspirin and clopidogrel or prasugrel or ticagrelor) for at least 6 months.
- Possible or defined thrombus (by angiography or endovascular imaging) in the target vessel.
The study team makes the final eligibility decision.
Where it's taking place
- Clermont-Ferrand, Auvergne, France
- Clermont-Ferrand, France
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Clermont-Ferrand, Auvergne, France; Clermont-Ferrand, France. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.