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The study objective is to assess the safety and efficacy of the Permanent Polymer Zotarolimus-Eluting Stent Resolute Integrityâ„¢ to the Polymer Free Amphilimus-Eluting Stent Cre8â„¢ compared in an all-comer patient population. 1 month of dual antiplatelet duration will be applied in stable angina pectoris patients. Myocardial infarction patient population will be treated with 12 months of dual antiplatelet therapy.
A Prospective, Multi-Center, Open Label, Randomized Controlled, two-arm Study to Evaluate the Safety and Efficacy of the Permanent Polymer Zotarolimus Eluting Stent 'Resolute Integrityâ„¢' Compared to Polymer Free Amphilimus Eluting Stent 'Cre8'. Dual Antiplatelet Therapy duration of 1 Month will be applied in stable angina pectoris patient population. Myocardial infarction patient population will be treated with 12 months of dual antiplatelet therapy (DAPT).
One thousand five hundred thirty-two (1532) patients (1:1 randomization Cre8 stent: Resolute Integrityâ„¢ stent) will be enrolled in the study, with clinical follow-up at 12 months to assess the primary end point.
After a period of 12 months, a clinical registry will be implemented Information will be collected at 3-years post procedure.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cre8 stent | Experimental | PCI with the Polymer Free Amphilimus Eluting Stent 'Cre8â„¢' |
|
| Resolute Integrity Stent | Active Comparator | Comparison of the Cre8 stent with the Permanent Polymer Zotarolimus Eluting Stent 'Resolute Integrityâ„¢' |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cre8 Stent | Device | Comparison of the Resolute Integrity stent with the Cre8 stent. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Target Lesion Failure (TLF) | Cardiac death, vessel-related myocardial infarction (QWMI and NQWMI), target lesion revascularization by CABG or PCI | 12 and 36 months |
| Measure | Description | Time Frame |
|---|---|---|
| Net Adverse Clinical Events (NACE) | defined as composite of any death, stroke, myocardial infarction, any unplanned repeated revascularization and bleeding (BARC 3a and above) | 12 and 36 months |
| Target lesion failure (TLF) |
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Inclusion Criteria:
General Inclusion Criteria:
Angiographic Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Pieter R Stella, M.D., PhD | Contact | +31-88-7556167 | p.stella@umcutrecht.nl |
| Name | Affiliation | Role |
|---|---|---|
| Pieter R Stella, M.D., PhD | UMC Utrecht, the Netherlands | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Institute of Cardiac Surgery and Interventional Cardiology | Recruiting | Luxembourg | Luxembourg |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38560639 | Derived | van Hemert ND, Stella PR, Rozemeijer R, Stein M, Frambach P, Kraaijeveld AO, Rittersma SZ, Meijs TA, Leenders GEH, van der Harst P, Agostoni P, Voskuil M; ReCre8 Study Investigators. High bleeding risk in patients undergoing percutaneous coronary intervention with drug-eluting stent implantation: ReCre8 subanalysis. Am Heart J Plus. 2022 Nov 9;24:100227. doi: 10.1016/j.ahjo.2022.100227. eCollection 2022 Dec. | |
| 34794654 |
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| ID | Term |
|---|---|
| D060050 | Angina, Stable |
| D054058 | Acute Coronary Syndrome |
| ID | Term |
|---|---|
| D000787 | Angina Pectoris |
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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| Resolute Integrity stent | Device |
|
separate components of the primary endpoint; cardiac death, vessel related myocardial infarction (QWMI and NQWMI), target lesion revascularization by CABG or PCI
| 12 and 36 months |
| Target vessel revascularization by CABG or PCI (TVR) | 12 and 36 months |
| Stent thrombosis | 12 and 36 months |
| Device, lesion and procedure success at time of baseline procedure | 12 and 36 months |
| Zuyderland Medical Centre | Recruiting | Heerlen | Netherlands |
|
| UMC Utrecht | Recruiting | Utrecht | 3584CM | Netherlands |
|
| Derived |
| van Hemert ND, Voskuil M, Rozemeijer R, Stein M, Frambach P, Pereira B, Rittersma SZ, Kraaijeveld AO, Leenders GEH, Timmers L, van der Harst P, Agostoni P, Stella PR; ReCre8 Study Investigators. 3-Year Clinical Outcomes After Implantation of Permanent-Polymer Versus Polymer-Free Stent: ReCre8 Landmark Analysis. JACC Cardiovasc Interv. 2021 Nov 22;14(22):2477-2486. doi: 10.1016/j.jcin.2021.08.078. |
| 30586704 | Derived | Rozemeijer R, Stein M, Voskuil M, van den Bor R, Frambach P, Pereira B, Koudstaal S, Leenders GE, Timmers L, Rittersma SZ, Kraaijeveld AO, Agostoni P, Roes KC, Doevendans PA, Stella PR; ReCre8 Study Investigators. Randomized All-Comers Evaluation of a Permanent Polymer Zotarolimus-Eluting Stent Versus a Polymer-Free Amphilimus-Eluting Stent. Circulation. 2019 Jan 2;139(1):67-77. doi: 10.1161/CIRCULATIONAHA.118.037707. |
| D014652 |
| Vascular Diseases |
| D002637 | Chest Pain |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |