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The purpose is to evaluate the safety and effectiveness of paclitaxel-releasing coronary balloon (Catheter SeQuent® Please) versus rapid exchange PTCA balloon catheter (SeQuent® Neo) in the treatment of stenoses of coronary small vessels. 270 subjects will be enrolled for the trials.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Paclitaxel-eluting PTCA-Balloon Catheter(SeQuent® Please) | Experimental |
| |
| Rapid exchange PTCA Balloon Catheter (SeQuent® Neo) | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Paclitaxel-eluting PTCA-Balloon Catheter(SeQuent® Please) | Device | SeQuent® Please in length of 10 mm, 15 mm, 17 mm, 20 mm, 26 mm, 30 mm and in diameter of 2.0 mm, 2.5mm, 2.75mm will be used in the trial. |
| Measure | Description | Time Frame |
|---|---|---|
| Late lumen loss in segment section at M9 | To measure the diameter loss in the in-segment late lumen loss (LLL) at 9 months after operation by using angiography | 9 months |
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Inclusion Criteria:
Criteria related to subjects
Criteria related to lesions
Exclusion Criteria:
Criteria related to subjects
Criteria related to lesions
Exclusion criteria related to concomitant medication
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jun Bo Ge | Contact | +86 21 64041990 | 2745 | lcsyjg@zs-hospital.sh.cn |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Zhongshan Hospital Fudan University | Recruiting | Shanghai | Shanghai Municipality | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41117656 | Derived | Xu K, Fu X, Yang W, Wu Y, Li C, Ding D, Wang Z, Chu M, Qian J, He B, Tu S, Shen L, Ge J. A novel angiographic index for predicting the efficacy of drug-coated balloons in small vessels. EuroIntervention. 2025 Oct 20;21(20):e1209-e1221. doi: 10.4244/EIJ-D-25-00075. |
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| rapid exchange PTCA -Balloon Catheter (SeQuent® Neo) | Device | SeQuent® Please in length of 10 mm, 15 mm, 17 mm, 20 mm, 26 mm, 30 mm and in diameter of 2.0 mm, 2.5mm, 2.75mm will be used in the trial. |
|