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The aim of the study is to investigate the non-inferiority of the new sirolimus-coated balloon catheters in comparison to the paclitaxel-coated SQP with regard to acute tolerance, safety and efficacy in coronary DES in-stent restenosis.
The aim of the study is to investigate the non-inferiority of the new sirolimus-coated balloon catheters in comparison to the paclitaxel-coated SQP with regard to acute tolerance, safety and efficacy in coronary DES in-stent restenosis.
Patient population will consist of male and female adults suffering from coronary drug-eluting stent (DES) restenosis, which is to be treated by a study balloon according to the inclusion and exclusion criteria as defined below.
In Late lumen loss lesion (difference between the angiographic in-lesion MLD post procedural and at 6 months follow-up) will be evaluated by quantitative coronary angiography (QCA).
The study will be performed as a single-blind, SQP controlled study in 4 - 6 study centers in 50 patients.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sirolimus coated Balloon | Experimental | treatment of coronary DES-ISR with a sirolimus coated balloon |
|
| Paclitaxel coated balloon (SeQuent Please) | Active Comparator | treatment of coronary DES-ISR with a paclitaxel coated balloon |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Paclitaxel coated balloon (SeQuent Please) | Device | Paclitaxel coated balloon (SeQuent Please) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Late lumen loss | Difference between minimal lumen diameter at follow-up coronary angiography and baseline after PCI | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Procedural Success | ≤ 30% final stenosis, TIMI III flow, no flow-limiting dissection at the conclusion of the procedure, and the absence of in-hospital (24 hour after treatment) MACE | 24 hours |
| MACE (Major adverse cardiac events) |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Queen Elizabeth Hospital II | Kota Kinabalu | 88300 | Malaysia | |||
| National Heart Institute |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36126132 | Derived | Scheller B, Mangner N, Abdul Kader MASK, Wan Ahmad WA, Jeger R, Wohrle J, Ong TK, Liew HB, Gori T, Mahfoud F, Nuruddin AA, Woitek F, Abidin IZ, Schwenke C, Schnorr B, Mohd Ali R. Combined Analysis of Two Parallel Randomized Trials of Sirolimus-Coated and Paclitaxel-Coated Balloons in Coronary In-Stent Restenosis Lesions. Circ Cardiovasc Interv. 2022 Sep;15(9):e012305. doi: 10.1161/CIRCINTERVENTIONS.122.012305. Epub 2022 Sep 20. | |
| 30898253 |
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| Sirolimus coated balloon | Device | Sirolimus coated balloon |
|
MACE will be defined as the occurrence of cardiac death, target vessel myocardial infarction, or clinically driven target lesion revascularization at 6 months and 12 months.
| 12 months |
| Kuala Lumpur |
| 50400 |
| Malaysia |
| University Malaya | Kuala Lumpur | 50603 | Malaysia |
| Sarawak Genaral Hospital Heart Centre | Kuching | 94300 | Malaysia |
| Hospital Pulau Pinang | Pulau Pinang | 10990 | Malaysia |
| Derived |
| Ali RM, Abdul Kader MASK, Wan Ahmad WA, Ong TK, Liew HB, Omar AF, Mahmood Zuhdi AS, Nuruddin AA, Schnorr B, Scheller B. Treatment of Coronary Drug-Eluting Stent Restenosis by a Sirolimus- or Paclitaxel-Coated Balloon. JACC Cardiovasc Interv. 2019 Mar 25;12(6):558-566. doi: 10.1016/j.jcin.2018.11.040. |