Coronary In-stent RestenosisSPRITNCT07920055
Sirolimus-Coated Versus Paclitaxel-Coated Balloon for Recurrent Coronary In-Stent Restenosis After Prior Paclitaxel-Coated Balloon Treatment (SPRIT)
A study testing SeQuent SCB sirolimus-coated balloon and RESTORE DEB paclitaxel-coated balloon in people with Coronary In-stent Restenosis and Coronary Artery Disease, run by Sir Run Run Shaw Hospital at 1 site in China.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coronary In-stent Restenosis, Coronary Artery Disease
- What is being tested?
- SeQuent SCB sirolimus-coated balloon and RESTORE DEB paclitaxel-coated balloon
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 106 participants
- Where
- 1 siteChina
- Study dates
- 1 Nov 2026to 30 Nov 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥18 years.
- Stable angina, acute coronary syndrome (NSTEMI at least 7 days after onset or STEMI at least 30 days after onset), prior myocardial infarction, or documented asymptomatic myocardial ischemia.
- Prior treatment of coronary in-stent restenosis with a paclitaxel-coated balloon alone; recurrent restenosis is in the previously treated segment, including 5 mm beyond the stent edge.
- Quantitative coronary angiography shows diameter stenosis ≥70%, or ≥50% with evidence of myocardial ischemia.
- Suitable for either type of coronary revascularization under study.
- Willing to take aspirin and clopidogrel for 3 months, followed by aspirin monotherapy through study completion.
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- Willing to undergo angiographic and IVUS follow-up at 9 months and clinical follow-up at 30 days and 6, 9, and 12 months.
- Able to understand the study, provide written informed consent, and comply with study procedures.
- At least one recurrent target in-stent restenosis lesion requiring intervention, in one target vessel, with no more than two target lesions; any other de novo lesion requiring intervention must be >10 mm away from a target lesion.
- Mehran type I, II, or III in-stent restenosis of a bare-metal, inert-coated, or drug-eluting stent; target reference vessel diameter 2.5-4.0 mm and each target-lesion length ≤34 mm.
Who cannot join
- Takayasu arteritis or active vasculitis.
- eGFR <30 mL/min/1.73 m² or dialysis.
- ALT or AST >3 times the upper limit of normal.
- Left ventricular ejection fraction <30%.
- Active bleeding, major bleeding within 3 months, or preprocedural hemoglobin <10 g/dL.
- Platelets <100,000/mm³ or INR >1.5 in the absence of anticoagulation.
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- Cardiogenic shock.
- Concomitant disease requiring cytotoxic treatment or radiotherapy.
- Known allergy or contraindication to aspirin, heparin, clopidogrel, sirolimus, ticagrelor, tirofiban, paclitaxel, or iopromide; or contrast allergy not manageable with prophylaxis.
- Bleeding diathesis or a condition such as gastrointestinal ulcer that limits or prevents required antithrombotic therapy.
- Pregnancy, planned pregnancy during the study, inability to use effective contraception through the 12-month visit, or breastfeeding.
- Critical illness or life expectancy ≤1 year.
- Participation in another interventional study.
- Investigator judgment that the participant is unsuitable for the study.
- Three-vessel disease requiring treatment (all three major epicardial vessels with ≥70% stenosis and ischemia) or left main coronary disease.
- More than three lesions expected to require treatment overall, or more than two lesions requiring treatment in any coronary artery.
- Target lesion with residual stenosis >30%, TIMI flow <3, or type C or worse dissection after predilatation.
- Target lesion with tortuosity, severe calcification, or angulation expected to prevent passage of the study balloon.
- Thrombus-containing target lesion.
- Prior coronary artery bypass grafting.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
Sir Run Run Shaw Hospital
Hangzhou
Wenbin Zhang, 0571-86006241, wzhang_crf@126.com
Wenbin Zhang
About this study
Official title: Sirolimus-Coated Balloon (SeQuent SCB) Versus Paclitaxel-Coated Balloon (RESTORE DEB) for Recurrent Coronary In-Stent Restenosis Following Prior Paclitaxel-Coated Balloon Therapy: A Multicenter, Randomized, Open-Label, Noninferiority Trial
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.
Read the detailed description
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.
- Being tested
- SeQuent SCB sirolimus-coated balloon, RESTORE DEB paclitaxel-coated balloon
- Keywords
- drug-coated balloon; sirolimus-coated balloon; paclitaxel-coated balloon; recurrent in-stent restenosis; quantitative coronary angiography; late lumen loss
- Medical subject headings
- Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SeQuent SCB sirolimus-coated balloonDevice
Coronary balloon angioplasty of eligible target lesions
RESTORE DEB paclitaxel-coated balloonDrug
Coronary balloon angioplasty of eligible target lesions
| Study group | Role | What they receive |
|---|---|---|
| SeQuent SCB Sirolimus-Coated Balloon | Experimental | 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 Receives: Device: SeQuent SCB sirolimus-coated balloon |
| RESTORE DEB Paclitaxel-Coated Balloon | Active comparator | 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 Receives: Drug: RESTORE DEB paclitaxel-coated balloon |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Immediately after index procedure and at 9 months
Secondary outcomes (17)
Device Success
Measured: During index procedure
Lesion Success
Measured: Immediately after index procedure
Clinical Success
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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
Measured: 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.
Measured: 9 months after index procedure
Target Lesion Failure
Cumulative incidence of cardiac death, target-vessel myocardial infarction, or clinically driven target lesion revascularization
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 6 and 12 months after index procedure
Device-Related Adverse Events
Proportion of participants experiencing a device-related adverse event.
Measured: 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.
Measured: From index procedure through 30 days and 6, 9, and 12 months
Serious Adverse Events
Proportion of participants experiencing a serious adverse event.
Measured: From index procedure through 30 days and 6, 9, and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Nov 2026
- Study start1 Nov 2026 (estimated)
- Primary completion31 Aug 2028 (estimated)
- Study completion30 Nov 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary In-stent RestenosisStudies of the same condition, open and under way.
- More trials run by Sir Run Run Shaw HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 106 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sir Run Run Shaw Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Wenbin Zhang, Sir Run Run Shaw Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07920055
- Sponsor's protocol ID
- SPRIT
- Acronym
- SPRIT
- Status last verified
- Oct 2026
- First submitted
- 30 Oct 2026
- Last updated
- 5 Nov 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sirolimus-Coated Balloon (SeQuent SCB) Versus Paclitaxel-Coated Balloon (RESTORE DEB) for Recurrent Coronary In-Stent Restenosis Following Prior Paclitaxel-Coated Balloon Therapy: A Multicenter, Randomized, Open-Label, Noninferiority Trial
- ClinicalTrials.gov ID
- NCT07920055
- Acronym / sponsor ID
- SPRIT / SPRIT
- Keywords
- drug-coated balloon; sirolimus-coated balloon; paclitaxel-coated balloon; recurrent in-stent restenosis; quantitative coronary angiography; late lumen loss
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 106 participants (estimated)
- Lead sponsor
- Sir Run Run Shaw HospitalUniversity, hospital or other
- Study start
- 1 Nov 2026 (estimated)
- Primary completion
- 31 Aug 2028 (estimated)
- Study completion
- 30 Nov 2028 (estimated)
- First posted
- 5 Nov 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SeQuent SCB Sirolimus-Coated Balloon | Experimental | Device: SeQuent SCB sirolimus-coated balloonTreatment 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 |
| RESTORE DEB Paclitaxel-Coated Balloon | Active comparator | Drug: RESTORE DEB paclitaxel-coated balloonTreatment 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Age ≥18 years.
- Stable angina, acute coronary syndrome (NSTEMI at least 7 days after onset or STEMI at least 30 days after onset), prior myocardial infarction, or documented asymptomatic myocardial ischemia.
- Prior treatment of coronary in-stent restenosis with a paclitaxel-coated balloon alone; recurrent restenosis is in the previously treated segment, including 5 mm beyond the stent edge.
- Quantitative coronary angiography shows diameter stenosis ≥70%, or ≥50% with evidence of myocardial ischemia.
- Suitable for either type of coronary revascularization under study.
Key exclusion criteria (20 listed)
- Takayasu arteritis or active vasculitis.
- eGFR <30 mL/min/1.73 m² or dialysis.
- ALT or AST >3 times the upper limit of normal.
- Left ventricular ejection fraction <30%.
- Active bleeding, major bleeding within 3 months, or preprocedural hemoglobin <10 g/dL.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SeQuent SCB sirolimus-coated balloonCoronary balloon angioplasty of eligible target lesions | Device | SeQuent SCB Sirolimus-Coated Balloon |
| RESTORE DEB paclitaxel-coated balloonCoronary balloon angioplasty of eligible target lesions | Drug | RESTORE DEB Paclitaxel-Coated Balloon |
Primary outcome
In-Segment Late Lumen Loss at 9 Months
Time frame: Immediately after index procedure and 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.
17 secondary outcomes
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
Time frame: 9 months after index procedure
In-Stent Late Lumen Area Loss at 9 Months by IVUS
Time frame: Immediately after index procedure and at 9 months
Neointimal Hyperplasia Area at 9 Months by IVUS
Time frame: 9 months after index procedure
Neointimal Hyperplasia Volume at 9 Months by IVUS
Time frame: 9 months after index procedure
Stent Malapposition at 9 Months by IVUS
Time frame: 9 months after index procedure
Edge Restenosis at 9 Months by IVUS
Time frame: 9 months after index procedure
Target Lesion Failure
Time frame: From index procedure through 30 days and 6, 9, and 12 months
Patient-Oriented Composite Endpoint
Time frame: From index procedure through 30 days and 6, 9, and 12 months
ARC-Defined Thrombotic Events
Time frame: From index procedure through 12 months
Seattle Angina Questionnaire Score
Time frame: 6 and 12 months after index procedure
SF-36 Health Survey Score
Time frame: 6 and 12 months after index procedure
Device-Related Adverse Events
Time frame: From index procedure through 30 days and 6, 9, and 12 months
Bleeding Events
Time frame: From index procedure through 30 days and 6, 9, and 12 months
Serious Adverse Events
Time frame: From index procedure through 30 days and 6, 9, and 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Nov 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SeQuent SCB sirolimus-coated balloon and RESTORE DEB paclitaxel-coated balloon in people with Coronary In-stent Restenosis and Coronary Artery Disease, run by Sir Run Run Shaw Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 5 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Wenbin Zhang (0571-86006241, wzhang_crf@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
In-Segment Late Lumen Loss at 9 Months (time frame: Immediately after index procedure and at 9 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Nov 2026.