Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Micell Technologies | INDUSTRY |
| Stentys | INDUSTRY |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The primary objective of this study is to compare the performance of MISTENT to that of XIENCE in an all-comers patient population with symptomatic ischemic heart disease. The patients will be followed through 3 years for major clinical events.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| MiStent® | Experimental | Percutaneous Coronary Intervention with the MiStent Sirolimus Eluting Absorbable Polymer Coronary Stent. It is a balloon expandable sirolimus eluting stent with an absorbable polymer coating. |
|
| XIENCE EES | Active Comparator | Percutaneous Coronary Intervention with the XIENCE EES (Everolimus Eluting) Coronary Stent System. The stents are balloon expandable drug eluting stents using everolimus with a non-erodible or durable polymer coating. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MiStent | Device | Percutaneous Coronary Intervention |
| |
| XIENCE EES |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Occurrence of a Device Oriented Composite Endpoint (DOCE) | DOCE is a composite of clinical endpoint of cardiac death, myocardial infarction not clearly attributable to a non-target vessel and clinically-indicated target lesion revascularization. | 12 months postprocedure |
| Measure | Description | Time Frame |
|---|---|---|
| POCE | POCE defined as all-cause death, any Myocardial Infarction (MI), or any revascularization | At 12 months |
| MACE | MACE defined as all-cause death, any MI, or any Target Vessel Revascularization (TVR) |
Not provided
Inclusion Criteria:
All comers" patients:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Ernest Spitzer, MD | European Cardiovascular Research Institute | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Center Corbeil | Corbeil | France | ||||
| Research Center Nimes |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29203070 | Background | de Winter RJ, Katagiri Y, Asano T, Milewski KP, Lurz P, Buszman P, Jessurun GAJ, Koch KT, Troquay RPT, Hamer BJB, Ophuis TO, Wohrle J, Wyderka R, Cayla G, Hofma SH, Levesque S, Zurakowski A, Fischer D, Kosmider M, Goube P, Arkenbout EK, Noutsias M, Ferrari MW, Onuma Y, Wijns W, Serruys PW. A sirolimus-eluting bioabsorbable polymer-coated stent (MiStent) versus an everolimus-eluting durable polymer stent (Xience) after percutaneous coronary intervention (DESSOLVE III): a randomised, single-blind, multicentre, non-inferiority, phase 3 trial. Lancet. 2018 Feb 3;391(10119):431-440. doi: 10.1016/S0140-6736(17)33103-3. Epub 2017 Dec 5. | |
| 34666500 |
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | MiStent® | Percutaneous Coronary Intervention with the MiStent Sirolimus Eluting Absorbable Polymer Coronary Stent. It is a balloon expandable sirolimus eluting stent with an absorbable polymer coating. MiStent: Percutaneous Coronary Intervention |
| FG001 | XIENCE EES | Percutaneous Coronary Intervention with the XIENCE EES (Everolimus Eluting) Coronary Stent System. The stents are balloon expandable drug eluting stents using everolimus with a non-erodible or durable polymer coating. XIENCE EES: Percutaneous Coronary Intervention |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | MiStent® | Percutaneous Coronary Intervention with the MiStent Sirolimus Eluting Absorbable Polymer Coronary Stent. It is a balloon expandable sirolimus eluting stent with an absorbable polymer coating. MiStent: Percutaneous Coronary Intervention |
| BG001 | XIENCE EES |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Participants With Occurrence of a Device Oriented Composite Endpoint (DOCE) | DOCE is a composite of clinical endpoint of cardiac death, myocardial infarction not clearly attributable to a non-target vessel and clinically-indicated target lesion revascularization. | Intention-to-treat | Posted | Count of Participants | Participants | 12 months postprocedure |
|
12 months (primary reporting), and yearly up to 5 years.
Adverse event reporting in the context of a post-marketing trial.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | MiStent® | Percutaneous Coronary Intervention with the MiStent Sirolimus Eluting Absorbable Polymer Coronary Stent. It is a balloon expandable sirolimus eluting stent with an absorbable polymer coating. MiStent: Percutaneous Coronary Intervention |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Myocardial infarction | Cardiac disorders | MEDDEV 2.7/3 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Non Serious AE | General disorders | MEDDEV 2.7/3 | Non-systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. E. Spitzer | European Cardiovascular Research Institute | +31102062828 | E.Spitzer@ECRI-Trials.com |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Mar 7, 2018 | Dec 8, 2021 | Prot_SAP_000.pdf |
Not provided
| ID | Term |
|---|---|
| D023921 | Coronary Stenosis |
| ID | Term |
|---|---|
| D003327 | Coronary Disease |
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Device |
Percutaneous Coronary Intervention |
|
| At 12 months |
| Target Vessel Failure (TVF) | Target Vessel Failure (TVF) defined as cardiac death, TV MI, or clinically indicated TVR | At 12 months |
| All-cause Death | All-cause death | At 12 months |
| Myocardial Infarction | Any Myocardial infarction | At 12 months |
| Any Revascularization | Any revascularization | At 12 months |
| Stent Thrombosis | Definite or probably stent thrombosis according to ARC | At 12 months |
| Nîmes |
| France |
| Research Center Poitiers | Poitiers | France |
| Research Center Jena | Jena | Germany |
| Research Center Leipzig | Leipzig | Germany |
| Research Center Munster | Münster | Germany |
| Research Center Ulm | Ulm | Germany |
| Research Center Wiesbaden | Wiesbaden | Germany |
| Research Center Amersfoort | Amersfoort | Netherlands |
| Research Center Amsterdam | Amsterdam | Netherlands |
| Tergooi | Blaricum | Netherlands |
| Research Center Emmen | Emmen | Netherlands |
| Research Center Leeuwarden | Leeuwarden | Netherlands |
| Research Center Nijmegen | Nijmegen | Netherlands |
| Research Center Venlo | Venlo | Netherlands |
| Research Center Belchatow | Bełchatów | Poland |
| Research Center Bielsko-Biala | Bielsko-Biala | Poland |
| Research center Chrzanow | Chrzanów | Poland |
| Research Center Tychy | Tychy | Poland |
| Research Center Zgierz | Zgierz | Poland |
| Derived |
| Wang R, Kawashima H, Hara H, Gao C, Ono M, Takahashi K, Tu S, Soliman O, Garg S, van Geuns RJ, Tao L, Wijns W, Onuma Y, Serruys PW. Comparison of Clinically Adjudicated Versus Flow-Based Adjudication of Revascularization Events in Randomized Controlled Trials. Circ Cardiovasc Qual Outcomes. 2021 Nov;14(11):e008055. doi: 10.1161/CIRCOUTCOMES.121.008055. Epub 2021 Oct 20. |
| 32888011 | Derived | Katagiri Y, Andreini D, Miyazaki Y, Takahashi K, Komiyama H, Mushtaq S, Sonck J, Schoors D, Maisano F, Kaufman PA, Leal I, Lindeboom W, Piek JJ, Wykrzykowska JJ, Morel MA, Bartorelli AL, Onuma Y, Serruys PW; SYNTAX III REVOLUTION Investigators. Site vs. core laboratory variability in computed tomographic angiography-derived SYNTAX scores in the SYNTAX III trial. Eur Heart J Cardiovasc Imaging. 2021 Aug 14;22(9):1063-1071. doi: 10.1093/ehjci/jeaa172. |
| 32466676 | Derived | Takahashi K, Serruys PW, Kogame N, Buszman P, Lurz P, Jessurun GAJ, Koch KT, Troquay RPT, Hamer BJB, Oude Ophuis T, Milewski KP, Hofma SH, Wykrzykowska JJ, Onuma Y, de Winter RJ, Wijns W. Final 3-Year Outcomes of MiStent Biodegradable Polymer Crystalline Sirolimus-Eluting Stent Versus Xience Permanent Polymer Everolimus-Eluting Stent: Insights From the DESSOLVE III All-Comers Randomized Trial. Circ Cardiovasc Interv. 2020 Jun;13(6):e008737. doi: 10.1161/CIRCINTERVENTIONS.119.008737. Epub 2020 May 29. |
Percutaneous Coronary Intervention with the XIENCE EES (Everolimus Eluting) Coronary Stent System. The stents are balloon expandable drug eluting stents using everolimus with a non-erodible or durable polymer coating. XIENCE EES: Percutaneous Coronary Intervention |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
Percutaneous Coronary Intervention with the XIENCE EES (Everolimus Eluting) Coronary Stent System. The stents are balloon expandable drug eluting stents using everolimus with a non-erodible or durable polymer coating.
XIENCE EES: Percutaneous Coronary Intervention
|
|
| Secondary | POCE | POCE defined as all-cause death, any Myocardial Infarction (MI), or any revascularization | ITT | Posted | Count of Participants | Participants | At 12 months |
|
|
|
| Secondary | MACE | MACE defined as all-cause death, any MI, or any Target Vessel Revascularization (TVR) | Posted | Count of Participants | Participants | At 12 months |
|
|
|
| Secondary | Target Vessel Failure (TVF) | Target Vessel Failure (TVF) defined as cardiac death, TV MI, or clinically indicated TVR | ITT | Posted | Count of Participants | Participants | At 12 months |
|
|
|
| Secondary | All-cause Death | All-cause death | ITT | Posted | Count of Participants | Participants | At 12 months |
|
|
|
| Secondary | Myocardial Infarction | Any Myocardial infarction | Posted | Count of Participants | Participants | At 12 months |
|
|
|
| Secondary | Any Revascularization | Any revascularization | Posted | Count of Participants | Participants | At 12 months |
|
|
|
| Secondary | Stent Thrombosis | Definite or probably stent thrombosis according to ARC | Posted | Count of Participants | Participants | At 12 months |
|
|
|
| 85 |
| 703 |
| 434 |
| 703 |
| 76 |
| 703 |
| EG001 | XIENCE EES | Percutaneous Coronary Intervention with the XIENCE EES (Everolimus Eluting) Coronary Stent System. The stents are balloon expandable drug eluting stents using everolimus with a non-erodible or durable polymer coating. XIENCE EES: Percutaneous Coronary Intervention | 78 | 695 | 426 | 695 | 71 | 695 |
| Definite stent thrombosis | Cardiac disorders | MEDDEV 2.7/3 | Systematic Assessment |
|
| Other | General disorders | MEDDEV 2.7/3 | Systematic Assessment |
|
Not provided
Not provided
| D014652 |
| Vascular Diseases |