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| ID | Type | Description | Link |
|---|---|---|---|
| G120123 | Other Identifier | FDA |
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The purpose of this study is to assess the safety and effectiveness of the SYNERGY Everolimus-Eluting Platinum Chromium Coronary Stent System for the treatment of subjects with atherosclerotic lesion(s) ≤ 34 mm in length (by visual estimate) in native coronary arteries ≥2.25 mm to ≤4.0 mm in diameter (by visual estimate).
A concurrent, non-randomized, single-arm, pharmacokinetic (PK) substudy and a consecutive, non-randomized, single-arm, Diabetes substudy will also enroll under the EVOLVE II protocol.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Promus Element Plus | Active Comparator | PROMUS Element Plus is a device/drug combination product composed of two components, a device (coronary stent system including a platinum chromium stent platform) and a drug product (a formulation of everolimus contained in a polymer coating). |
|
| SYNERGY | Experimental | SYNERGY is a device/drug combination product composed of two components, a device (coronary stent system including a platinum chromium stent platform) and a drug product (a formulation of everolimus contained in a bioabsorbable polymer coating). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PROMUS Element Plus | Device | A drug eluting coronary stent system |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With Target Lesion Failure (TLF) at 12 Months | TLF is defined as any ischemia-driven revascularization of the target lesion, myocardial infarction (Q-wave and non-Q-wave) related to the target vessel, or cardiac death. | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With Target Lesion Revascularization (TLR) at 12 Months. | The TLR overall rate includes: TLR Percutaneous Coronary Intervention (PCI) & TLR Coronary Artery Bypass Graft (CABG). | 12 months |
| Percentage of Participants With Target Vessel Revascularization (TVR) at 12 Months. |
Not provided
Inclusion Criteria:
Angiographic Inclusion Criteria (visual estimate):
Exclusion Criteria:
Subject has clinical symptoms and/or electrocardiogram (ECG) changes consistent with acute ST elevation MI (STEMI)
Subject has cardiogenic shock, hemodynamic instability requiring inotropic or mechanical circulatory support, intractable ventricular arrhythmias, or ongoing intractable angina
Subject has received an organ transplant or is on a waiting list for an organ transplant
Subject is receiving or scheduled to receive chemotherapy within 30 days before or after the index procedure
Planned PCI (including staged procedures) or CABG after the index procedure
Subject previously treated at any time with intravascular brachytherapy
_ Subject has a known allergy to contrast (that cannot be adequately premedicated) and/or the trial stent system or protocol-required concomitant medications (e.g., platinum, platinum-chromium alloy, stainless steel, everolimus or structurally related compounds, polymer or individual components, all P2Y12 inhibitors, or aspirin)
Subject has one of the following (as assessed prior to the index procedure):
Subject is receiving chronic (≥72 hours) anticoagulation therapy (i.e., heparin, coumadin) for indications other than acute coronary syndrome
Subject has a platelet count <100,000 cells/mm3 or >700,000 cells/mm3
Subject has a white blood cell (WBC) count < 3,000 cells/mm3
Subject has documented or suspected liver disease, including laboratory evidence of hepatitis
Subject is on dialysis or has baseline serum creatinine level >2.0 mg/dL (177µmol/L)
Subject has a history of bleeding diathesis or coagulopathy or will refuse blood transfusions
Subject has had a history of cerebrovascular accident (CVA) or transient ischemic attack (TIA) within the past 6 months
Subject has an active peptic ulcer or active gastrointestinal (GI) bleeding
Subject has severe symptomatic heart failure (i.e., NYHA class IV)
Subject is participating in another investigational drug or device clinical trial that has not reached its primary endpoint
Subject intends to participate in another investigational drug or device clinical trial within 12 months after the index procedure
Subject with known intention to procreate within 12 months after the index procedure (women of child-bearing potential who are sexually active must agree to use a reliable method of contraception from the time of screening through 12 months after the index procedure)
Subject is a woman who is pregnant or nursing (a pregnancy test must be performed within 7 days prior to the index procedure in women of child-bearing potential)
Angiographic Exclusion Criteria (visual estimate):
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| Name | Affiliation | Role |
|---|---|---|
| Peter M Maurer, MPH | Boston Scientific Corporation | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Baptist Medical Center - Princeton | Birmingham | Alabama | 35211 | United States | ||
| Banner Good Samaritan Medical Center |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31451014 | Derived | Kereiakes DJ, Windecker S, Jobe RL, Mehta SR, Sarembock IJ, Feldman RL, Stein B, Dubois C, Grady T, Saito S, Kimura T, Underwood P, Allocco DJ, Meredith IT. Clinical Outcomes Following Implantation of Thin-Strut, Bioabsorbable Polymer-Coated, Everolimus-Eluting SYNERGY Stents. Circ Cardiovasc Interv. 2019 Sep;12(9):e008152. doi: 10.1161/CIRCINTERVENTIONS.119.008152. Epub 2019 Aug 27. | |
| 25855680 |
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A total of 1684 patients have been enrolled in the study Evolve II Randomizes Clinical trial (RCT) from 26 November 2012 until 29 Aug 2013.
The Evolve II RCT study is anticipated to be completed (final 5-year follow-up) in 2018.
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| ID | Title | Description |
|---|---|---|
| FG000 | Promus Element Plus | PROMUS Element Plus is a device/drug combination product composed of two components, a device (coronary stent system including a platinum chromium stent platform) and a drug product (a formulation of everolimus contained in a polymer coating). PROMUS Element Plus: A drug eluting coronary stent system |
| FG001 |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| SYNERGY |
| Device |
A drug eluting coronary stent system |
|
TVR overall includes: TVR PCI & TVR CABG. |
| 12 months |
| Percentage of Participants With Target Vessel Failure (TVF) at 12 Month. | Target Vessel Failure is defined as any ischemic-driven revascularization of the target vessel, MI related to the target vessel, or any cardiac death. | 12 months |
| Percentage of Participants With Myocardial Infarction at 12 Month. | The MI rate includes: MI's related to the Target Vessel, MI's with unknown relationship to the Target Vessel and MI's not related to the Target Vessel. | 12 months |
| Percentage of Participants With Cardiac Death at 12 Month. | 12 months |
| Percentage of Participants With Non-Cardiac Death at 12 Month. | 12 months |
| Percentage of Patients That Died at 12 Months. | The Death rate includes Cardiac- & Non-Cardiac Death. | 12 months |
| Percentage of Patients With Cardiac Death or Myocardial Infarction (MI) at 12 Month. | 12 months |
| Percentage of Participants Who Died or Had an Myocardial Infarction (MI) at 12 Month. | 12 months |
| Percentage of Participants Who Died, Had an Myocardial Infarction (MI) or a Target Vessel Revascularization (TVR) at12 Month. | 12 months |
| Percentage of Participants With a ARC (Academic Research Consortium) Stent Thrombosis Rate at 12 Month. | 12 months |
| Percentage of Patients With a Stroke at 12 Month. | The stroke rate includes: Ischemic- , Hemorraghic- & Undetermined Stroke. | 12 months |
| Periprocedural Technical Success Rate. | Technical Success Rate is defined as successful delivery and deployment of the study stent to the target vessel, without balloon rupture or stent embolization, and post-procedure diameter stenosis less then 30% in 2 near-orthogonal projections with TIMI 3 flow in the target lesion. Technical success is lesion based. | Day 1 (periprocedure) |
| Periprocedural Clinical Procedural Success Rate | Procedural Success Rate is defined as post-procedure diameter less then 30% in 2 near-orthogonal projections with TIMI 3 flow in all target lesions without occurrence of in-hospital cardiac death, MI, TVR. Procedural success rate is subject based. | Day 1 (periprocedure) |
| Percentage of Participants With a Target Lesion Failure (TLF) at 12 Month. | 12 month |
| Percentage of Patients With Revascularization (=All Revascularizations) at 12 Month. | All CEC adjudicated revascularization at 12 month (Intent to treat population). | 12 Month |
| Phoenix |
| Arizona |
| 85006 |
| United States |
| Arkansas Heart Hospital | Little Rock | Arkansas | 72211 | United States |
| Bakersfield Memorial Hospital | Bakersfield | California | 93301 | United States |
| University of California Davis Health System | Sacramento | California | 95617 | United States |
| Sutter Memorial Hospital | Sacramento | California | 95819 | United States |
| Alvarado Hospital Medical Center | San Diego | California | 92121 | United States |
| North Colorado Medical Center | Greeley | Colorado | 80631 | United States |
| South Denver Cardiology Associates, PC | Littleton | Colorado | 80120 | United States |
| Washington Hospital Center | Washington D.C. | District of Columbia | 20010 | United States |
| Morton Plant Mease Healthcare | Clearwater | Florida | 33756 | United States |
| University of Miami McKnight Brain Institute | Miami | Florida | 33138 | United States |
| MediQuest | Ocala | Florida | 34471 | United States |
| Florida Hospital Medical Center | Orlando | Florida | 32803 | United States |
| Tallahassee Research Institute, Inc. | Tallahassee | Florida | 32308 | United States |
| Medical Center of Central Georgia | Macon | Georgia | 31201 | United States |
| Wellstar Health Systems | Marietta | Georgia | 30060 | United States |
| Kaiser Foundation Hospital | Honolulu | Hawaii | 96819 | United States |
| Kootenai Medical Center | Coeur d'Alene | Idaho | 83814 | United States |
| Prairie Cardiovascular Consultants, Ltd. | Springfield | Illinois | 62701 | United States |
| Northern Indiana Research Alliance | Fort Wayne | Indiana | 46804 | United States |
| St. Vincent's Medical Group, Inc. | Indianapolis | Indiana | 46290 | United States |
| Genesis Medical Center | Davenport | Iowa | 52803 | United States |
| Mercy Hospital Medical Center | Des Moines | Iowa | 50314 | United States |
| Kings Daughters Medical Center | Ashland | Kentucky | 41101 | United States |
| Maine Medical Center | Portland | Maine | 04102 | United States |
| MedStar Union Memorial Hospital | Baltimore | Maryland | 21218 | United States |
| Tufts Medical Center, Inc. | Boston | Massachusetts | 02110 | United States |
| Brigham & Women's Hospital | Boston | Massachusetts | 02120 | United States |
| Beth Israel Deaconess Medical Center | Boston | Massachusetts | 02215 | United States |
| Lahey Clinic Medical Center - Burlington | Burlington | Massachusetts | 01805 | United States |
| Henry Ford Health System | Detroit | Michigan | 48202 | United States |
| Genesys Regional Medical Center | Grand Blanc | Michigan | 48439 | United States |
| Northern Michigan Hospital | Petoskey | Michigan | 49770 | United States |
| St Mary's Duluth Clinic | Duluth | Minnesota | 55805 | United States |
| Abbott Northwestern Hospital | Minneapolis | Minnesota | 55407 | United States |
| North Mississippi Medical Center | Tupelo | Mississippi | 38801 | United States |
| Saint Luke's Hospital of Kansas City | Kansas City | Missouri | 64111 | United States |
| Washington University School of Medicine | St Louis | Missouri | 63110 | United States |
| Deborah Heart and Lung Center | Browns Mills | New Jersey | 08015 | United States |
| Our Lady of Lourdes Medical Center | Haddon Heights | New Jersey | 08035 | United States |
| Morristown Medical Center | Morristown | New Jersey | 07960 | United States |
| New Mexico Heart Institute, PA | Albuquerque | New Mexico | 87042 | United States |
| Mount Sinai - PRIME | New York | New York | 10029 | United States |
| Columbia University Medical Center | New York | New York | 10032 | United States |
| New York Presbyterian Hospital | New York | New York | 10065 | United States |
| Moses H. Cone Memorial Hospital-LeBauer Cardiovascular Research Foundation | Greensboro | North Carolina | 27401 | United States |
| Rex Hospital | Raleigh | North Carolina | 27607 | United States |
| Wake Heart Research, LLC | Raleigh | North Carolina | 27610 | United States |
| Wake Forest University | Winston-Salem | North Carolina | 27157 | United States |
| Lindner Center for Research and Education at Christ Hosp | Cincinnati | Ohio | 45219 | United States |
| University Hospitals Case Medical Center | Cleveland | Ohio | 44103 | United States |
| Ohio State University Medical Center | Columbus | Ohio | 43210 | United States |
| Mercy St. Vincent Medical Center | Toledo | Ohio | 43608 | United States |
| Oklahoma Heart Hospital | Oklahoma City | Oklahoma | 73120 | United States |
| Providence Portland Medical Center | Portland | Oregon | 97213 | United States |
| Geisinger Clinic | Danville | Pennsylvania | 17822 | United States |
| Pennsylvania Hospital | Philadelphia | Pennsylvania | 19107 | United States |
| Temple University Hospital | Philadelphia | Pennsylvania | 19140 | United States |
| Sisters of Charity Providence Hospitals | Columbia | South Carolina | 29204 | United States |
| Jackson Madison County Hospital | Jackson | Tennessee | 38301 | United States |
| Centennial Medical Center | Nashville | Tennessee | 37203 | United States |
| Baylor Heart & Vascular Hospital | Dallas | Texas | 75226 | United States |
| Medical City Dallas Hospital | Dallas | Texas | 75230 | United States |
| St. David's Round Rock Medical Center | Round Rock | Texas | 78681 | United States |
| Methodist Texsan Hospital | San Antonio | Texas | 78201 | United States |
| Henrico Doctors Hospital | Richmond | Virginia | 23229 | United States |
| Swedish Medical Center | Seattle | Washington | 98122 | United States |
| Aspirus Heart & Vascular Institute | Wausau | Wisconsin | 54401 | United States |
| The Prince Charles Hospital | Chermside | Queensland | 4032 | Australia |
| Monash Medical Centre-Clayton Campus | Clayton | Victoria | 3168 | Australia |
| St Vincent's Hospital Melbourne | Fitzroy | Victoria | 3065 | Australia |
| Fremantle Hospital | Fremantle | Western Australia | 6160 | Australia |
| LKH - Universitätsklinikum der PMU Salzburg | Salzburg | Austria |
| AKH - Medizinische Universität Wien | Vienna | Austria |
| Imelda Ziekenhuis | Bonheiden | 2820 | Belgium |
| Z.O.L - Campus St. Jan | Genk | 3600 | Belgium |
| UZ Leuven | Leuven | 3000 | Belgium |
| HHrm | Roeselare | 8800 | Belgium |
| Foothills Medical Centre | Calgary | Alberta | T2N 2T9 | Canada |
| Hamilton Health Sciences | Hamilton | Ontario | L8L 2X2 | Canada |
| Sunnybrook Health Sciences Centre | Toronto | Ontario | M4N 3M4 | Canada |
| Institut de Cardiologie de Montreal | Montreal | Quebec | H1T 1C8 | Canada |
| Institut Universitaire de Cardiologie et de Pneumologie de Quebec | Sainte-Foy | Quebec | G1V 4G5 | Canada |
| Rigshospitalet Copenhagen | Copenhagen | 2100 | Denmark |
| University Hospital, Heart Centre | Tampere | 33521 | Finland |
| Turku University Hospital | Turku | FI-20520 | Finland |
| CHU de Brest - Hôpital de la Cavale Blanche | Brest | Finistere | 29609 | France |
| CHU de Toulouse - Hôpital Rangueil | Toulouse | Haute Garonne | 31059 | France |
| Clinique Pasteur - Toulouse | Toulouse | Haute Garonne | 31076 | France |
| Hôpital Cardio-Vasculaire et Pneumologique Louis Pradel | Bron | Rhone | 69500 | France |
| Clinique Saint-Hilaire - Centre Frédéric Joliot | Rouen | Seine Maritime | 76000 | France |
| Polyclinique Les Fleurs | Ollioules | Var | 83192 | France |
| Centre Hospitalier de Lagny - Marne La Vallée | Lagny-sur-Marne | 77600 | France |
| Hôpital Cochin | Paris | 75014 | France |
| Istituto Clinico Humanitas | Rozzano | Milano | 20089 | Italy |
| Umberto I Pol. di Roma-Università di Roma La Sapienza | Roma | 161 | Italy |
| Azienda Ospedaliera Città della Salute e della Scienza di Torino | Torino | 10126 | Italy |
| Kokura Memorial Hospital | Kitakyushu-shi | Fukuoka | 802-8555 | Japan |
| Kurume University Hospital | Kurume-shi | Fukuoka | 830-0011 | Japan |
| Shonan Kamakura General Hospital | Kamakura-shi | Kanagawa | 247-8533 | Japan |
| Saiseikai Yokohamashi Tobu Hospital | Yokohama | Kanagawa | 230-8765 | Japan |
| Kyoto University Hospital | Kyoto | Kyoto | 606-8507 | Japan |
| National Cerebral and Cardiovascular Center | Suita-shi | Osaka | 565-8565 | Japan |
| Teikyo University Hospital | Itabashi-ku | Tokyo-To | 173-8606 | Japan |
| Nihon University Itabashi Hospital | Itabashi-ku | Tokyo-To | 173-8610 | Japan |
| Toho University Ohashi Medical Center | Meguro-ku | Tokyo-To | 153-8515 | Japan |
| The Cardiovascular Institute | Minatoku | Tokyo-To | 106-0031 | Japan |
| Showa University Hospital | Shinagawa-ku | Tokyo-To | 142-8666 | Japan |
| Department of Cardiology, Tokyo Women's Medical University | Shinjuku-ku | Tokyo-To | 162-8666 | Japan |
| P. Stradins Clinical University Hospital | Riga | LV1002 | Latvia |
| Medisch Centrum Alkmaar | Alkmaar | 1815 JD | Netherlands |
| Medisch Spectrum Twente, Haaksbergerstraat | Enschede | 7513 ER | Netherlands |
| St. Antonius Ziekenhuis, Nieuwegein | Nieuwegein | 3435CM | Netherlands |
| Ascot Angiography Ltd | Auckland | 1050 | New Zealand |
| Middlemore Hospital | Auckland | 1640 | New Zealand |
| North Shore Hospital | Auckland | 622 | New Zealand |
| Christchurch Hospital NZ | Christchurch | 8011 | New Zealand |
| SPZOZ Szpital Uniwersytecki w Krakowie | Krakow | 31-501 | Poland |
| SK Przemienienia Panskiego UM im.K.Marcinkowskiego | Poznan | 61-848 | Poland |
| Instytut Kardiologii im.Prymasa Tysiaclecia Kardynala Stefana Wyszynskiego | Warsaw | 04-628 | Poland |
| National University Hospital | Singapore | 119228 | Singapore |
| National Heart Centre | Singapore | 168752 | Singapore |
| Hospital Clinic de Barcelona | Barcelona | 8036 | Spain |
| Hospital Universitario ClÃnico San Carlos | Madrid | 28040 | Spain |
| Hospital Universitario La Paz | Madrid | 28046 | Spain |
| Derived |
| Kereiakes DJ, Meredith IT, Windecker S, Lee Jobe R, Mehta SR, Sarembock IJ, Feldman RL, Stein B, Dubois C, Grady T, Saito S, Kimura T, Christen T, Allocco DJ, Dawkins KD. Efficacy and safety of a novel bioabsorbable polymer-coated, everolimus-eluting coronary stent: the EVOLVE II Randomized Trial. Circ Cardiovasc Interv. 2015 Apr;8(4):e002372. doi: 10.1161/CIRCINTERVENTIONS.114.002372. |
| SYNERGY |
SYNERGY is a device/drug combination product composed of two components, a device (coronary stent system including a platinum chromium stent platform) and a drug product (a formulation of everolimus contained in a bioabsorbable polymer coating). SYNERGY: A drug eluting coronary stent system |
| Completed 12-Month Clinical F/U |
|
| No 12-Month F/U |
|
| Death With No 12-month Clinical FU |
|
| COMPLETED |
|
| NOT COMPLETED |
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Promus Element Plus | PROMUS Element Plus is a device/drug combination product composed of two components, a device (coronary stent system including a platinum chromium stent platform) and a drug product (a formulation of everolimus contained in a polymer coating). PROMUS Element Plus: A drug eluting coronary stent system |
| BG001 | SYNERGY | SYNERGY is a device/drug combination product composed of two components, a device (coronary stent system including a platinum chromium stent platform) and a drug product (a formulation of everolimus contained in a bioabsorbable polymer coating). SYNERGY: A drug eluting coronary stent system |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | yr |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Race/Ethnicity, Customized | The Ethnicity and Race data are not mutually exclusive. For example: subject can check both "Asian" and "Native Hawaiian or other Pacific Islander", or "Caucasian" and "Hispanic or Latino". Therefore the sum of participants in all Categories for the Measure does not equal the Overall Number of Baseline Participants in the Arm/Group | Number | participants |
| |||||||||||||||
| Region of Enrollment | Number | participants |
| ||||||||||||||||
| Height | Mean | Standard Deviation | inches |
| |||||||||||||||
| Weight | Mean | Standard Deviation | lbs |
| |||||||||||||||
| Smoking | Number | participants |
| ||||||||||||||||
| Current Diabetes Mellitus | Number | participants |
| ||||||||||||||||
| Hyperlipidemia Requiring Medication | Number | participants |
| ||||||||||||||||
| Hypertension Requiring Medication | Number | participants |
| ||||||||||||||||
| History of bleeding disorder | Number | participants |
| ||||||||||||||||
| History of GI bleeding | Number | participants |
| ||||||||||||||||
| History of Transient Ischemic Attack | Number | participants |
| ||||||||||||||||
| History of cerebrovascular accident | Number | participants |
| ||||||||||||||||
| History of Transient Ischemic Attack (TIA) or Cerebrovasular Accident (CVA) | Number | participants |
| ||||||||||||||||
| History of peripheral vascular disease (PVD) | Number | participants |
| ||||||||||||||||
| History of renal disease | Number | participants |
| ||||||||||||||||
| Baseline Lesion Characteristics as determined by the Angiographic Core Laboratory, ITT Analysis Set | The Promus Element Plus group has 1043 lesions in 838 subjects enrolled in this treatment arm. The Synergy group has 1059 lesions in 846 subjects enrolled in this treatment arm. The measure type is number of lesions. The total number of lesions does not match with the total number of participants since some of the participants have more than one lesion. | Number | Number of lesions |
|
| 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 | Percentage of Participants With Target Lesion Failure (TLF) at 12 Months | TLF is defined as any ischemia-driven revascularization of the target lesion, myocardial infarction (Q-wave and non-Q-wave) related to the target vessel, or cardiac death. | The per protocol population was used for this analysis. Therefore the number of participants analyzed is not consistent with the numbers provided in participant flow module. | Posted | Number | percentage of participants | 12 months |
|
|
| |||||||||||||||||||||||||||||
| Secondary | Percentage of Participants With Target Lesion Revascularization (TLR) at 12 Months. | The TLR overall rate includes: TLR Percutaneous Coronary Intervention (PCI) & TLR Coronary Artery Bypass Graft (CABG). | Intent-to-Treat population | Posted | Number | percentage of participants | 12 months |
|
| ||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants With Target Vessel Revascularization (TVR) at 12 Months. | TVR overall includes: TVR PCI & TVR CABG. | Intent-to- Treat | Posted | Number | percentage of participants | 12 months |
|
| ||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants With Target Vessel Failure (TVF) at 12 Month. | Target Vessel Failure is defined as any ischemic-driven revascularization of the target vessel, MI related to the target vessel, or any cardiac death. | Intent-to-treat analysis | Posted | Number | percentage of participants | 12 months |
|
| ||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants With Myocardial Infarction at 12 Month. | The MI rate includes: MI's related to the Target Vessel, MI's with unknown relationship to the Target Vessel and MI's not related to the Target Vessel. | Intent-to-treat | Posted | Number | percentage of participants | 12 months |
|
| ||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants With Cardiac Death at 12 Month. | Intent-to-treat population | Posted | Number | percentage of participants | 12 months |
|
| |||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants With Non-Cardiac Death at 12 Month. | Intent-to-treat population | Posted | Number | percentage of participants | 12 months |
|
| |||||||||||||||||||||||||||||||
| Secondary | Percentage of Patients That Died at 12 Months. | The Death rate includes Cardiac- & Non-Cardiac Death. | Intent-to-treat population | Posted | Number | percentage of participants | 12 months |
|
| ||||||||||||||||||||||||||||||
| Secondary | Percentage of Patients With Cardiac Death or Myocardial Infarction (MI) at 12 Month. | Intent-to-treat population | Posted | Number | percentage of participants | 12 months |
|
| |||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants Who Died or Had an Myocardial Infarction (MI) at 12 Month. | Intent-to-treat population | Posted | Number | percentage of participants | 12 months |
|
| |||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants Who Died, Had an Myocardial Infarction (MI) or a Target Vessel Revascularization (TVR) at12 Month. | Intent-to-treat population | Posted | Number | percentage of participants | 12 months |
|
| |||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants With a ARC (Academic Research Consortium) Stent Thrombosis Rate at 12 Month. | Intent-to-treat population. | Posted | Number | percentage of participants | 12 months |
|
| |||||||||||||||||||||||||||||||
| Secondary | Percentage of Patients With a Stroke at 12 Month. | The stroke rate includes: Ischemic- , Hemorraghic- & Undetermined Stroke. | Intent-to-Treat population. | Posted | Number | percentage of participants | 12 months |
|
| ||||||||||||||||||||||||||||||
| Secondary | Periprocedural Technical Success Rate. | Technical Success Rate is defined as successful delivery and deployment of the study stent to the target vessel, without balloon rupture or stent embolization, and post-procedure diameter stenosis less then 30% in 2 near-orthogonal projections with TIMI 3 flow in the target lesion. Technical success is lesion based. | Intent-to-Treat analysis set. Promus Element Plus population: 838 subject analyzed with 1043 lesions treated with technical success achieved in 1011 lesions. SYNERGY population: 846 subjects analyzed with 1059 lesions treated with technical success achieved in 1041 lesions. | Posted | Number | percentage of lesions | Day 1 (periprocedure) |
| |||||||||||||||||||||||||||||||
| Secondary | Periprocedural Clinical Procedural Success Rate | Procedural Success Rate is defined as post-procedure diameter less then 30% in 2 near-orthogonal projections with TIMI 3 flow in all target lesions without occurrence of in-hospital cardiac death, MI, TVR. Procedural success rate is subject based. | Intent-to-Treat population | Posted | Number | percentage of subjects | Day 1 (periprocedure) |
|
| ||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants With a Target Lesion Failure (TLF) at 12 Month. | Intent-to-Treat population | Posted | Number | percentage of participants | 12 month |
|
| |||||||||||||||||||||||||||||||
| Secondary | Percentage of Patients With Revascularization (=All Revascularizations) at 12 Month. | All CEC adjudicated revascularization at 12 month (Intent to treat population). | Intent to treat population | Posted | Number | percentage of patients | 12 Month |
|
|
Site-Reported Serious Adverse Events to 12 Months
Not provided
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 | Promus Element Plus | PROMUS Element Plus is a device/drug combination product composed of two components, a device (coronary stent system including a platinum chromium stent platform) and a drug product (a formulation of everolimus contained in a polymer coating). PROMUS Element Plus: A drug eluting coronary stent system | 262 | 838 | 576 | 838 | ||
| EG001 | SYNERGY | SYNERGY is a device/drug combination product composed of two components, a device (coronary stent system including a platinum chromium stent platform) and a drug product (a formulation of everolimus contained in a bioabsorbable polymer coating). SYNERGY: A drug eluting coronary stent system | 265 | 846 | 567 | 846 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Cardiac disorders | Cardiac disorders |
| |||
| General disorders and administration site conditions | General disorders |
| |||
| Nervous sysytem disorders | Nervous system disorders |
| |||
| Injury, poisining and procedural complications | Injury, poisoning and procedural complications |
| |||
| Respiratory, thoracic and mediastinal disorders | Respiratory, thoracic and mediastinal disorders |
| |||
| Infections and infestations | Infections and infestations |
| |||
| Vascular disorders | Vascular disorders |
| |||
| Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Neoplasms benign, malignant and unspecified (incl cysts and polyps) |
| |||
| Gastrointestinal disorders | Gastrointestinal disorders |
| |||
| Blood and lymphatic system disorders | Blood and lymphatic system disorders |
| |||
| Renal and Urinary disorders | Renal and urinary disorders |
| |||
| Musculoskeletal and connective tissue disorders | Musculoskeletal and connective tissue disorders |
| |||
| Metabolism and nutrition disorders | Metabolism and nutrition disorders |
| |||
| Psychiatric disorders | Psychiatric disorders |
| |||
| Eye disorders | Eye disorders |
| |||
| Hepatobiliary disorders | Hepatobiliary disorders |
| |||
| Investigations | Investigations |
| |||
| Endocrine disorders | Endocrine disorders |
| |||
| Ear and labyrinth disorders | Ear and labyrinth disorders |
| |||
| Skin and subcutaneous tissue disorders | Skin and subcutaneous tissue disorders |
| |||
| Immune system disorders | Immune system disorders |
| |||
| Congenital, familial and genetic disorders | Congenital, familial and genetic disorders |
| |||
| Reproductive system and breast disorders | Reproductive system and breast disorders |
| |||
| Surgical and medical procedures | Surgical and medical procedures |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Angina Pectoris | Cardiac disorders |
| |||
| Myocardial infarction | Cardiac disorders |
| |||
| Coronary artery dissection | Cardiac disorders |
| |||
| Angina unstable | Cardiac disorders |
| |||
| Acute myocardial infarction | Cardiac disorders |
| |||
| Atrial fibrillation | Cardiac disorders |
| |||
| Cardiac failure congestive | Cardiac disorders |
| |||
| Bradycardia | Cardiac disorders |
| |||
| Palpitations | Cardiac disorders |
| |||
| Ventricular tachycardia | Cardiac disorders |
| |||
| Dyspnoea | Respiratory, thoracic and mediastinal disorders |
| |||
| Epistaxis | Respiratory, thoracic and mediastinal disorders |
| |||
| Cough | Respiratory, thoracic and mediastinal disorders |
| |||
| Dyspnoea exertional | Respiratory, thoracic and mediastinal disorders |
| |||
| Dizziness | Nervous system disorders |
| |||
| Headache | Nervous system disorders |
| |||
| Syncope | Nervous system disorders |
| |||
| Nausea | Gastrointestinal disorders |
| |||
| Gastrointestinal haemorrhage | Gastrointestinal disorders |
| |||
| Abdominal pain | Gastrointestinal disorders |
| |||
| Rectal Haemorrhage | Gastrointestinal disorders |
| |||
| Pain in extremity | Musculoskeletal and connective tissue disorders |
| |||
| Back Pain | Musculoskeletal and connective tissue disorders |
| |||
| Arthralgia | Musculoskeletal and connective tissue disorders |
| |||
| Myalgia | Musculoskeletal and connective tissue disorders |
| |||
| Pneumonia | Infections and infestations |
| |||
| Urinary tract infection | Infections and infestations |
| |||
| Nasopharyngitis | Infections and infestations |
| |||
| Contusion | Injury, poisoning and procedural complications |
| |||
| Hypertension | Vascular disorders |
| |||
| Hypotension | Vascular disorders |
| |||
| Cardiac enzymes increased | Investigations |
| |||
| Troponin increased | Investigations |
| |||
| Haematuria | Renal and urinary disorders |
| |||
| Anaemia | Blood and lymphatic system disorders |
| |||
| Drug hypersensitivity | Immune system disorders |
|
The sponsor can review results communications to public release and can embargo communications regarding trial results for a period less or equal to 45 days from the time submitted to the sponsor. If the sponsor determines the communication would be detrimental to the intellectual property, the PI will redact or modify or will refrain the publication to a publisher or other party for an additional 120 days to permit the sponsor to file patent applications or take other steps to protect interests
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Patricia O'Mara, Clinical Trial Manager | Boston Scientific | 518-792-5673 | patricia.o'mara@bsci.com |
| ID | Term |
|---|---|
| D003324 | Coronary Artery Disease |
| ID | Term |
|---|---|
| D003327 | Coronary Disease |
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D001161 | Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |
Not provided
Not provided
| Male |
|
| Asian |
|
| Black,of African heritage |
|
| Caucasian |
|
| Hispanic or Latino |
|
| Native Hawaiian or other Pacific Islander |
|
| Other |
|
| Not Disclosed |
|
| United States |
|
| Japan |
|
| Spain |
|
| New Zealand |
|
| Canada |
|
| Latvia |
|
| Netherlands |
|
| Austria |
|
| Belgium |
|
| Finland |
|
| Denmark |
|
| Poland |
|
| Italy |
|
| Australia |
|
| France |
|
| Smoking,Unknown |
|
| Smoking, Never |
|
| No Current Diabetes Mellitus |
|
| No Hyperlipidemia requiring Medication |
|
| No Hypertension requiring medication |
|
| No history of bleeding disorder |
|
| No History of GI Bleeding |
|
| No History of Transient Ischemic Attack |
|
| No History of Cerebrovascular Accident |
|
| No history of TIA or CVA |
|
| No History of PVD |
|
| No History of renal disease |
|
| Left Circumflex Artery (LCx) |
|
| Right Coronary Artery (RCA) |
|
| Left Main Coronary Artery (LMCA) |
|
|
|
|
|
|
|
|
|
|
|
|
|
| Units | Counts |
|---|---|
| Participants |
|
|
|
|
|
|