An interventional study of SeQuent SCB sirolimus-coated balloon and RESTORE DEB paclitaxel-coated balloon in Coronary In-stent Restenosis and Coronary Artery Disease, sponsored by Sir Run Run Shaw Hospital. Not yet recruiting at 1 site in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-11-05.
Sponsored by Sir Run Run Shaw Hospital · Not applicable, Interventional, and Treatment
This prospective, multicenter, randomized, open-label, noninferiority trial will compare a sirolimus-coated balloon (SeQuent SCB) with a paclitaxel-coated balloon (RESTORE DEB) in 106 adults with recurrent coronary in-stent restenosis after prior paclitaxel-coated balloon treatment of the same segment. Participants will be randomized 1:1 to treatment of the target lesion with one of the study devices. The primary outcome is in-segment late lumen loss on quantitative coronary angiography 9 months after the index procedure. Clinical follow-up is scheduled at 30 days and 6, 9, and 12 months. Angiographic analysis and clinical event adjudication will be performed blinded to treatment assignment.
Eligible patients have recurrent restenosis in a previously stented coronary segment that was treated with a paclitaxel-coated balloon. Up to two eligible lesions in one target vessel may be treated per participant. Randomization through a central interactive web response system uses stratified blocks based on Mehran in-stent restenosis type (I vs II/III), target-lesion length (≤20 vs >20 mm), and reference vessel diameter (≤3.0 vs >3.0 mm). The assigned balloon will be used according to the protocol and instructions for use. Participants are scheduled to receive aspirin plus clopidogrel for 3 months followed by aspirin monotherapy until study completion. Coronary angiography is planned at 9 months; intravascular ultrasound is assessed immediately after treatment and at 9 months according to the protocol. The primary comparison is the between-group difference in 9-month in-segment late lumen loss (SeQuent SCB minus RESTORE DEB), with a noninferiority margin of 0.25 mm. An independent core laboratory performs blinded quantitative coronary angiographic measurements, and a blinded clinical events committee adjudicates clinical events.
4,857 studies on the registry are indexed under Coronary Artery Disease; 890 are open to participants now.
This study's planned enrollment of 106 is below the median of 124 across 3,006 interventional studies indexed under Coronary Artery Disease.
Browse Coronary Artery Disease studies →Sir Run Run Shaw Hospital is the lead sponsor of 135 studies on the registry; 72 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Blood tests of how long blood takes to clot. The INR is the prothrombin time (PT) put on a common scale; about 1 is usual for someone not taking a blood thinner.
Criteria often make an exception for people on a blood thinner such as warfarin, whose INR is raised on purpose.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
GFR and eGFR (kidney filtering)
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ALT and AST (liver enzymes)
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ULN (upper limit of normal)
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
LVEF (left ventricular ejection fraction)
The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hemoglobin (Hb)
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Platelets
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
INR, PT and aPTT (clotting tests)
Blood tests of how long blood takes to clot. The INR is the prothrombin time (PT) put on a common scale; about 1 is usual for someone not taking a blood thinner.
Criteria often make an exception for people on a blood thinner such as warfarin, whose INR is raised on purpose.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Life expectancy
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Treatment of eligible recurrent coronary in-stent restenosis with SeQuent SCB sirolimus-coated balloon angioplasty. Up to two balloons may be used per participant under the protocol. All participants receive protocol-directed antiplatelet treatment
Device: SeQuent SCB sirolimus-coated balloon
Treatment of eligible recurrent coronary in-stent restenosis with RESTORE DEB paclitaxel-coated balloon angioplasty. Up to two balloons may be used per participant under the protocol. All participants receive protocol-directed antiplatelet treatment
Drug: RESTORE DEB paclitaxel-coated balloon
Coronary balloon angioplasty of eligible target lesions
Coronary balloon angioplasty of eligible target lesions
In-Segment Late Lumen Loss at 9 Months
Difference, in millimeters, between the in-segment minimum lumen diameter immediately after balloon angioplasty and the minimum lumen diameter in the same segment at 9 months, measured by blinded quantitative coronary angiography. The prespecified noninferiority margin for the adjusted mean difference (SeQuent SCB minus RESTORE DEB) is 0.25 mm.
Time frame: Immediately after index procedure and at 9 months
Device Success
Time frame: During index procedure
Lesion Success
Time frame: Immediately after index procedure
Clinical Success
Time frame: During index hospitalization
In-Segment Binary Restenosis at 9 Months
Proportion of treated lesions with ≥50% diameter stenosis in the treated segment on 9-month quantitative coronary angiography
Time frame: 9 months after index procedure
In-Stent Late Lumen Area Loss at 9 Months by IVUS
Difference, in square millimeters, between the in-stent minimum lumen area immediately after treatment and at 9 months, measured by intravascular ultrasound.
Time frame: Immediately after index procedure and at 9 months
Neointimal Hyperplasia Area at 9 Months by IVUS
Neointimal hyperplasia area measured by intravascular ultrasound at the 9-month assessment; report in square millimeters.
Time frame: 9 months after index procedure
Neointimal Hyperplasia Volume at 9 Months by IVUS
Neointimal hyperplasia volume measured by intravascular ultrasound at the 9-month assessment; report in cubic millimeters
Time frame: 9 months after index procedure
Stent Malapposition at 9 Months by IVUS
Proportion of evaluated lesions with stent malapposition on intravascular ultrasound, according to the prespecified imaging definition
Time frame: 9 months after index procedure
Edge Restenosis at 9 Months by IVUS
Proportion of evaluated lesions with edge restenosis on intravascular ultrasound, according to the prespecified imaging definition.
Time frame: 9 months after index procedure
Target Lesion Failure
Cumulative incidence of cardiac death, target-vessel myocardial infarction, or clinically driven target lesion revascularization
Time frame: From index procedure through 30 days and 6, 9, and 12 months
Patient-Oriented Composite Endpoint
Cumulative incidence of all-cause death, any myocardial infarction, or any repeat revascularization
Time frame: From index procedure through 30 days and 6, 9, and 12 months
ARC-Defined Thrombotic Events
Incidence of definite, probable, or possible thrombosis classified as acute, subacute, or late according to the protocol's Academic Research Consortium definitions
Time frame: From index procedure through 12 months
Seattle Angina Questionnaire Score
Seattle Angina Questionnaire score at each scheduled assessment; specify the instrument version and score/domain to be analyzed in the final protocol
Time frame: 6 and 12 months after index procedure
SF-36 Health Survey Score
Short Form-36 health-related quality-of-life score at each scheduled assessment; specify component or domain scores in the final protocol
Time frame: 6 and 12 months after index procedure
Device-Related Adverse Events
Proportion of participants experiencing a device-related adverse event.
Time frame: From index procedure through 30 days and 6, 9, and 12 months
Bleeding Events
Proportion of participants experiencing a bleeding event; grading standard to be specified in the final protocol.
Time frame: From index procedure through 30 days and 6, 9, and 12 months
Serious Adverse Events
Proportion of participants experiencing a serious adverse event.
Time frame: From index procedure through 30 days and 6, 9, and 12 months
Plan to share: No
No publications or documents are linked to this record.
Start is estimated for Nov 2026; primary completion for Aug 2028, 21 months later.
Of 753 non-industry interventional studies with no phase under Coronary Artery Disease, half reached primary completion within 33 months of starting (the median), counting those still running; a quarter within 15 and three quarters within 53. This study's planned 21 months is below that.
Counting every sponsor, half of 930 studies reached it within 30 months; a quarter within 15 and three quarters within 50.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is not yet recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.
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