Sirolimus-Coated Versus Paclitaxel-Coated Balloon for Recurrent Coronary In-Stent Restenosis After Prior Paclitaxel-Coated Balloon Treatment (SPRIT)
NCT07920055, Not applicable, Not yet recruiting, Sir Run Run Shaw Hospital
Trial 10
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
| Field | Value | Source |
|---|---|---|
| Title | Sirolimus-Coated Versus Paclitaxel-Coated Balloon for Recurrent Coronary In-Stent Restenosis After Prior Paclitaxel-Coated Balloon Treatment (SPRIT) | ClinicalTrials.gov |
| NCT number | NCT07920055 | ClinicalTrials.gov |
| Status | Not yet recruiting | ClinicalTrials.gov |
| Phases | Not applicable | ClinicalTrials.gov |
| Enrollment | 106 participants, estimated | ClinicalTrials.gov |
| Lead sponsor | Sir Run Run Shaw Hospital | ClinicalTrials.gov |
| Conditions | Coronary In-stent Restenosis, Coronary Artery Disease | ClinicalTrials.gov |
| Interventions | SeQuent SCB sirolimus-coated balloon, RESTORE DEB paclitaxel-coated balloon | ClinicalTrials.gov |
| First posted | 2026-11-05 | ClinicalTrials.gov |
| Last updated | 2026-11-05 | ClinicalTrials.gov |
Registered outcomes 18
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description | Source |
|---|---|---|---|---|
| Primary | In-Segment Late Lumen Loss at 9 Months | 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. | ClinicalTrials.gov |
| Secondary | Device Success | During index procedure | ClinicalTrials.gov | |
| Secondary | Lesion Success | Immediately after index procedure | ClinicalTrials.gov | |
| Secondary | Clinical Success | During index hospitalization | ClinicalTrials.gov | |
| Secondary | In-Segment Binary Restenosis at 9 Months | 9 months after index procedure | Proportion of treated lesions with ≥50% diameter stenosis in the treated segment on 9-month quantitative coronary angiography | ClinicalTrials.gov |
| Secondary | In-Stent Late Lumen Area Loss at 9 Months by IVUS | Immediately after index procedure and at 9 months | Difference, in square millimeters, between the in-stent minimum lumen area immediately after treatment and at 9 months, measured by intravascular ultrasound. | ClinicalTrials.gov |
| Secondary | Neointimal Hyperplasia Area at 9 Months by IVUS | 9 months after index procedure | Neointimal hyperplasia area measured by intravascular ultrasound at the 9-month assessment; report in square millimeters. | ClinicalTrials.gov |
| Secondary | Neointimal Hyperplasia Volume at 9 Months by IVUS | 9 months after index procedure | Neointimal hyperplasia volume measured by intravascular ultrasound at the 9-month assessment; report in cubic millimeters | ClinicalTrials.gov |
| Secondary | Stent Malapposition at 9 Months by IVUS | 9 months after index procedure | Proportion of evaluated lesions with stent malapposition on intravascular ultrasound, according to the prespecified imaging definition | ClinicalTrials.gov |
| Secondary | Edge Restenosis at 9 Months by IVUS | 9 months after index procedure | Proportion of evaluated lesions with edge restenosis on intravascular ultrasound, according to the prespecified imaging definition. | ClinicalTrials.gov |
| Secondary | Target Lesion Failure | From index procedure through 30 days and 6, 9, and 12 months | Cumulative incidence of cardiac death, target-vessel myocardial infarction, or clinically driven target lesion revascularization | ClinicalTrials.gov |
| Secondary | Patient-Oriented Composite Endpoint | From index procedure through 30 days and 6, 9, and 12 months | Cumulative incidence of all-cause death, any myocardial infarction, or any repeat revascularization | ClinicalTrials.gov |
| Secondary | ARC-Defined Thrombotic Events | From index procedure through 12 months | Incidence of definite, probable, or possible thrombosis classified as acute, subacute, or late according to the protocol's Academic Research Consortium definitions | ClinicalTrials.gov |
| Secondary | Seattle Angina Questionnaire Score | 6 and 12 months after index procedure | Seattle Angina Questionnaire score at each scheduled assessment; specify the instrument version and score/domain to be analyzed in the final protocol | ClinicalTrials.gov |
| Secondary | SF-36 Health Survey Score | 6 and 12 months after index procedure | Short Form-36 health-related quality-of-life score at each scheduled assessment; specify component or domain scores in the final protocol | ClinicalTrials.gov |
| Secondary | Device-Related Adverse Events | From index procedure through 30 days and 6, 9, and 12 months | Proportion of participants experiencing a device-related adverse event. | ClinicalTrials.gov |
| Secondary | Bleeding Events | From index procedure through 30 days and 6, 9, and 12 months | Proportion of participants experiencing a bleeding event; grading standard to be specified in the final protocol. | ClinicalTrials.gov |
| Secondary | Serious Adverse Events | From index procedure through 30 days and 6, 9, and 12 months | Proportion of participants experiencing a serious adverse event. | ClinicalTrials.gov |
Outcomes 0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as | Source |
|---|
Results by group 0
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units | Source |
|---|
Participant flow 0
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted | Source |
|---|
Adverse events 0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events | Source |
|---|
Adverse event totals 0
The totals the trial posted for each group.
| Total | Group | Affected | At risk | Source |
|---|
Papers 0
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as | Source |
|---|
Grants 0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years | Source |
|---|
Trial comparisons 0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|
Tests 0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
| Test | Named as | Source |
|---|
Source 5
| Field | Value | Source |
|---|---|---|
| Release | trials-2026-11-12-0.4.0 | ClinicalTrials.gov |
| Release manifest SHA-256 | 0f4a8d8c48aee2a7573ae0fa94ecbeab70c1adbe449bbc95c424bc7d3e97b9d4 | ClinicalTrials.gov |
| Registry capture | 2026-11-12 | ClinicalTrials.gov |
| Results copy, AACT | 2026-03-23 | ClinicalTrials.gov |
| NIH clinical studies file | 2026-11-13 | ClinicalTrials.gov |
Release trials-2026-11-12-0.4.0
ClinicalTrials.gov's posted results, through CTTI's AACT: ClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299 ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
ClinicalTrials.gov: none stated ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
NIH RePORTER's clinical studies and project files: Public domain (NIH RePORTER)