Trial Outcomes & Findings for A Clinical Trial to Assess the SYNERGY 48 mm Stent System for the Treatment of Atherosclerotic Lesion(s) (NCT NCT03350542)

Last Updated: 2021-05-14

Results Overview

The primary endpoint is the 12-month Target Lesion Failure (TLF) rate, defined as any ischemia-driven revascularization of the target lesion (TLR), myocardial infarction (MI, Q-wave and non-Q-wave) related to the target vessel, or cardiac death.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

100 participants

Primary outcome timeframe

12-month

Results posted on

2021-05-14

Participant Flow

A total of 100 patients have been enrolled in the study from April 12, 2018 until January 17, 2019. The Evolve 48 study is anticipated to be completed (final 2-year follow up) in 2021.

Participant milestones

Participant milestones
Measure	SYNERGY 48 mm SYNERGY 48 mm 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 48 mm: A drug eluting coronary stent system
Overall Study STARTED	100
Overall Study Completed 12-Month Clinical F/U	96
Overall Study Death With no 12-month F/U	4
Overall Study COMPLETED	96
Overall Study NOT COMPLETED	4

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

For baseline categorical variables, "unknown" responses and missing values will not be counted in rate denominators

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	SYNERGY 48mm n=100 Participants SYNERGY is a device/drug combination product comprised of two regulated components: a device (Coronary Stent System) and a drug product (a formulation of everolimus contained in a bioabsorbable polymer coating).
Age, Continuous	64.99 years STANDARD_DEVIATION 10.57 • n=100 Participants
Sex: Female, Male Female	40 Participants n=100 Participants
Sex: Female, Male Male	60 Participants n=100 Participants
Race/Ethnicity, Customized American Indian or Alaska native	0 Participants n=100 Participants
Race/Ethnicity, Customized Black, of African heritage	6 Participants n=100 Participants
Race/Ethnicity, Customized Caucasian	85 Participants n=100 Participants
Race/Ethnicity, Customized Hispanic	3 Participants n=100 Participants
Race/Ethnicity, Customized Native Hawaiian or other Pacific Islander	1 Participants n=100 Participants
Race/Ethnicity, Customized Other	5 Participants n=100 Participants
Race/Ethnicity, Customized Not disclosed	0 Participants n=100 Participants
Region of Enrollment New Zealand	19 participants n=100 Participants
Region of Enrollment Latvia	3 participants n=100 Participants
Region of Enrollment United States	45 participants n=100 Participants
Region of Enrollment United Kingdom	33 participants n=100 Participants
Smoking Smoking, ever	51 Participants n=100 Participants
Smoking Smoking, current	14 Participants n=100 Participants
Smoking Smoking, previous	37 Participants n=100 Participants
Medically Treated Diabetes	27 Participants n=100 Participants
Hyperlipidemia requiring medication	82 Participants n=100 Participants
Hypertension requiring medication	76 Participants n=100 Participants
History of bleeding disorder	4 Participants n=100 Participants
History of Transient Ischemic Attack (TIA) or Coronary vasospasm (CVA)	4 Participants n=99 Participants • For baseline categorical variables, "unknown" responses and missing values will not be counted in rate denominators
History of TIA	4 Participants n=98 Participants • For baseline categorical variables, "unknown" responses and missing values will not be counted in rate denominators
History of CVA	0 Participants n=99 Participants • For baseline categorical variables, "unknown" responses and missing values will not be counted in rate denominators
History of renal disease	10 Participants n=100 Participants
History of Peripheral Vascular Disease (PVD)	10 Participants n=99 Participants • For baseline categorical variables, "unknown" responses and missing values will not be counted in rate denominators
Baseline lesion characteristics as determined by the Angiographic core lab, ITT analysis set Left Anterior Descending (LAD)	40 Participants n=100 Participants
Baseline lesion characteristics as determined by the Angiographic core lab, ITT analysis set Left Circumflex Artery (LCx)	14 Participants n=100 Participants
Baseline lesion characteristics as determined by the Angiographic core lab, ITT analysis set Right Coronary Artery (RCA)	46 Participants n=100 Participants
Baseline lesion characteristics as determined by the Angiographic core lab, ITT analysis set Left Main Coronary Artery (LMCA)	0 Participants n=100 Participants

PRIMARY outcome

Timeframe: 12-month

Population: The per-protocol and ITT populations are the same.

Outcome measures

Outcome measures
Measure	SYNERGY 48 mm n=98 Participants SYNERGY 48 mm 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 48 mm: A drug eluting coronary stent system
Target Lesion Failure Rate at 12-months	4 percentage of participants

SECONDARY outcome

Timeframe: 12 months

Population: Intent-to-Treat population

The TLR overall rate includes: TLR Percutaneous Coronary Intervention (PCI) and TLR Coronary Artery Bypass Graft (CABG)

Outcome measures

Outcome measures
Measure	SYNERGY 48 mm n=100 Participants SYNERGY 48 mm 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 48 mm: A drug eluting coronary stent system
Target Lesion Revascularization (TLR) Rate at 12 Months	1 percentage of participants

SECONDARY outcome

Timeframe: 12 months

Population: Intent-to-Treat

TVR overall includes: TVR PCI and TVR CABG

Outcome measures

Outcome measures
Measure	SYNERGY 48 mm n=100 Participants SYNERGY 48 mm 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 48 mm: A drug eluting coronary stent system
Target Vessel Revascularization (TVR) Rate at 12 Months.	1 percentage of participants

SECONDARY outcome

Timeframe: 12 months

Population: Intent-to-Treat analysis

Target Vessel Failure is defined as any ischemic-driven revascularization of the target vessel, MI related to the target vessel, or any cardiac death.

Outcome measures

Outcome measures
Measure	SYNERGY 48 mm n=100 Participants SYNERGY 48 mm 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 48 mm: A drug eluting coronary stent system
Target Vessel Failure (TVF) Rate at 12 Months	4 percentage of participants

SECONDARY outcome

Timeframe: 12 months

Population: Intent-to-Treat analysis

The MI rate includes: MIs related to the Target Vessel, MIs with unknown relationship to the Target Vessel and MIs not related to the Target Vessel.

Outcome measures

Outcome measures
Measure	SYNERGY 48 mm n=100 Participants SYNERGY 48 mm 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 48 mm: A drug eluting coronary stent system
MI (Q-wave and Non-Q-wave) Rate	2 percentage of participants

SECONDARY outcome

Timeframe: 12 months

Population: Intent-to-Treat

Cardiac death is defined as death due to any of the following; acute MI, cardiac perforation/pericardial tamponade, arrhythmia or conduction abnormality, CVA through hospital discharge or CVA suspected of being related to the procedure, death due to complication of the procedure, including bleeding, vascular repair, transfusion reaction, or bypass surgery and any death in which a cardiac cause cannot be excluded.

Outcome measures

Outcome measures
Measure	SYNERGY 48 mm n=100 Participants SYNERGY 48 mm 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 48 mm: A drug eluting coronary stent system
Cardiac Death Rate	1 percentage of participants

SECONDARY outcome

Timeframe: 12 months

Non-cardiac death is defined as a death not due to cardiac causes as previously defined.

Outcome measures

Outcome measures
Measure	SYNERGY 48 mm n=100 Participants SYNERGY 48 mm 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 48 mm: A drug eluting coronary stent system
Non-cardiac Death Rate	4 percentage of participants

SECONDARY outcome

Timeframe: 12 months

Outcome measures

Outcome measures
Measure	SYNERGY 48 mm n=100 Participants SYNERGY 48 mm 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 48 mm: A drug eluting coronary stent system
All Death Rate	5 percentage of participants

SECONDARY outcome

Timeframe: 12 months

Outcome measures

Outcome measures
Measure	SYNERGY 48 mm n=100 Participants SYNERGY 48 mm 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 48 mm: A drug eluting coronary stent system
Cardiac Death or MI Rate	3 percentage of participants

SECONDARY outcome

Timeframe: 12 months

Population: Intent-to-Treat

Outcome measures

Outcome measures
Measure	SYNERGY 48 mm n=100 Participants SYNERGY 48 mm 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 48 mm: A drug eluting coronary stent system
All Death or MI Rate	6 percentage of participants

SECONDARY outcome

Timeframe: 12 months

Outcome measures

Outcome measures
Measure	SYNERGY 48 mm n=100 Participants SYNERGY 48 mm 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 48 mm: A drug eluting coronary stent system
All Death/MI/TVR Rate	7 percentage of participants

SECONDARY outcome

Timeframe: 12 months

Population: Intent-to-Treat

Outcome measures

Outcome measures
Measure	SYNERGY 48 mm n=100 Participants SYNERGY 48 mm 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 48 mm: A drug eluting coronary stent system
Stent Thrombosis Rate	0 percentage of participants

SECONDARY outcome

Timeframe: Day 1 (periprocedural)

Population: Intent-to-Treat

Successful delivery and deployment of the study stent to the target vessel, without balloon rupture or stent embolization, and post-procedure diameter stenosis of \<30% in 2 near-orthogonal projections with Thrombolysis in Myocardial Infarction (TIMI) 3 flow in the target lesion, as visually assessed by the physician.

Outcome measures

Outcome measures
Measure	SYNERGY 48 mm n=100 Participants SYNERGY 48 mm 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 48 mm: A drug eluting coronary stent system
Periprocedural Technical Success Rate	100 percentage of participants

SECONDARY outcome

Timeframe: 12 months

Population: Intent-to-Treat

Post-procedure lesion diameter stenosis \<30% in 2 near-orthogonal projections with TIMI 3 flow in the target lesion, as visually assessed by the physician, without the occurrence of in-hospital cardiac death, MI, or TVR.

Outcome measures

Outcome measures
Measure	SYNERGY 48 mm n=100 Participants SYNERGY 48 mm 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 48 mm: A drug eluting coronary stent system
Periprocedural Clinical Procedural Success Rate	100 percentage of participants

Adverse Events

SYNERGY 48 mm

Serious events: 31 serious events

Other events: 4 other events

Deaths: 5 deaths

Serious adverse events

Serious adverse events
Measure	SYNERGY 48 mm n=100 participants at risk SYNERGY 48 mm 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 48 mm: A drug eluting coronary stent system
Cardiac disorders Coronary artery dissection	8.0% 8/100 • Site-Reported Serious Adverse Events (SAE) to 12 Months For All Cause Mortality, the at risk population (denominator) is the ITT population. For the SAE/AE tables, the at risk population (denominator) is the ITT population.
Injury, poisoning and procedural complications Plaque shift	3.0% 3/100 • Site-Reported Serious Adverse Events (SAE) to 12 Months For All Cause Mortality, the at risk population (denominator) is the ITT population. For the SAE/AE tables, the at risk population (denominator) is the ITT population.
Gastrointestinal disorders Colitis	1.0% 1/100 • Site-Reported Serious Adverse Events (SAE) to 12 Months For All Cause Mortality, the at risk population (denominator) is the ITT population. For the SAE/AE tables, the at risk population (denominator) is the ITT population.
Renal and urinary disorders Acute kidney injury	4.0% 4/100 • Site-Reported Serious Adverse Events (SAE) to 12 Months For All Cause Mortality, the at risk population (denominator) is the ITT population. For the SAE/AE tables, the at risk population (denominator) is the ITT population.
Nervous system disorders Carotid artery stenosis	2.0% 2/100 • Site-Reported Serious Adverse Events (SAE) to 12 Months For All Cause Mortality, the at risk population (denominator) is the ITT population. For the SAE/AE tables, the at risk population (denominator) is the ITT population.
Infections and infestations Osteomyelitis	1.0% 1/100 • Site-Reported Serious Adverse Events (SAE) to 12 Months For All Cause Mortality, the at risk population (denominator) is the ITT population. For the SAE/AE tables, the at risk population (denominator) is the ITT population.
Vascular disorders Intermittent claudication	1.0% 1/100 • Site-Reported Serious Adverse Events (SAE) to 12 Months For All Cause Mortality, the at risk population (denominator) is the ITT population. For the SAE/AE tables, the at risk population (denominator) is the ITT population.
Blood and lymphatic system disorders Haemorrhagic anaemia	1.0% 1/100 • Site-Reported Serious Adverse Events (SAE) to 12 Months For All Cause Mortality, the at risk population (denominator) is the ITT population. For the SAE/AE tables, the at risk population (denominator) is the ITT population.
Respiratory, thoracic and mediastinal disorders Pulmonary embolism	1.0% 1/100 • Site-Reported Serious Adverse Events (SAE) to 12 Months For All Cause Mortality, the at risk population (denominator) is the ITT population. For the SAE/AE tables, the at risk population (denominator) is the ITT population.
General disorders Non-cardiac chest pain	1.0% 1/100 • Site-Reported Serious Adverse Events (SAE) to 12 Months For All Cause Mortality, the at risk population (denominator) is the ITT population. For the SAE/AE tables, the at risk population (denominator) is the ITT population.
Hepatobiliary disorders Bile duct stone	1.0% 1/100 • Site-Reported Serious Adverse Events (SAE) to 12 Months For All Cause Mortality, the at risk population (denominator) is the ITT population. For the SAE/AE tables, the at risk population (denominator) is the ITT population.
Metabolism and nutrition disorders Fluid overload	1.0% 1/100 • Site-Reported Serious Adverse Events (SAE) to 12 Months For All Cause Mortality, the at risk population (denominator) is the ITT population. For the SAE/AE tables, the at risk population (denominator) is the ITT population.
Musculoskeletal and connective tissue disorders Back pain	1.0% 1/100 • Site-Reported Serious Adverse Events (SAE) to 12 Months For All Cause Mortality, the at risk population (denominator) is the ITT population. For the SAE/AE tables, the at risk population (denominator) is the ITT population.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Metastases to central nervous system	1.0% 1/100 • Site-Reported Serious Adverse Events (SAE) to 12 Months For All Cause Mortality, the at risk population (denominator) is the ITT population. For the SAE/AE tables, the at risk population (denominator) is the ITT population.
Psychiatric disorders Anxiety	1.0% 1/100 • Site-Reported Serious Adverse Events (SAE) to 12 Months For All Cause Mortality, the at risk population (denominator) is the ITT population. For the SAE/AE tables, the at risk population (denominator) is the ITT population.
Cardiac disorders Angina pectoris	4.0% 4/100 • Site-Reported Serious Adverse Events (SAE) to 12 Months For All Cause Mortality, the at risk population (denominator) is the ITT population. For the SAE/AE tables, the at risk population (denominator) is the ITT population.
Cardiac disorders Acute coronary syndrome	2.0% 2/100 • Site-Reported Serious Adverse Events (SAE) to 12 Months For All Cause Mortality, the at risk population (denominator) is the ITT population. For the SAE/AE tables, the at risk population (denominator) is the ITT population.
Cardiac disorders Cardiac failure congestive	2.0% 2/100 • Site-Reported Serious Adverse Events (SAE) to 12 Months For All Cause Mortality, the at risk population (denominator) is the ITT population. For the SAE/AE tables, the at risk population (denominator) is the ITT population.
Cardiac disorders Acute myocardial infarction	1.0% 1/100 • Site-Reported Serious Adverse Events (SAE) to 12 Months For All Cause Mortality, the at risk population (denominator) is the ITT population. For the SAE/AE tables, the at risk population (denominator) is the ITT population.
Cardiac disorders Angina unstable	1.0% 1/100 • Site-Reported Serious Adverse Events (SAE) to 12 Months For All Cause Mortality, the at risk population (denominator) is the ITT population. For the SAE/AE tables, the at risk population (denominator) is the ITT population.
Cardiac disorders Cardiac arrest	1.0% 1/100 • Site-Reported Serious Adverse Events (SAE) to 12 Months For All Cause Mortality, the at risk population (denominator) is the ITT population. For the SAE/AE tables, the at risk population (denominator) is the ITT population.
Cardiac disorders Cardiogenic shock	1.0% 1/100 • Site-Reported Serious Adverse Events (SAE) to 12 Months For All Cause Mortality, the at risk population (denominator) is the ITT population. For the SAE/AE tables, the at risk population (denominator) is the ITT population.
Cardiac disorders Cardiomyopathy	1.0% 1/100 • Site-Reported Serious Adverse Events (SAE) to 12 Months For All Cause Mortality, the at risk population (denominator) is the ITT population. For the SAE/AE tables, the at risk population (denominator) is the ITT population.
Cardiac disorders Chronic left ventricular failure	1.0% 1/100 • Site-Reported Serious Adverse Events (SAE) to 12 Months For All Cause Mortality, the at risk population (denominator) is the ITT population. For the SAE/AE tables, the at risk population (denominator) is the ITT population.
Cardiac disorders Coronary artery disease	1.0% 1/100 • Site-Reported Serious Adverse Events (SAE) to 12 Months For All Cause Mortality, the at risk population (denominator) is the ITT population. For the SAE/AE tables, the at risk population (denominator) is the ITT population.
Cardiac disorders Coronary artery stenosis	1.0% 1/100 • Site-Reported Serious Adverse Events (SAE) to 12 Months For All Cause Mortality, the at risk population (denominator) is the ITT population. For the SAE/AE tables, the at risk population (denominator) is the ITT population.
Injury, poisoning and procedural complications Alcohol poisoning	1.0% 1/100 • Site-Reported Serious Adverse Events (SAE) to 12 Months For All Cause Mortality, the at risk population (denominator) is the ITT population. For the SAE/AE tables, the at risk population (denominator) is the ITT population.
Injury, poisoning and procedural complications Craniocerebral injury	1.0% 1/100 • Site-Reported Serious Adverse Events (SAE) to 12 Months For All Cause Mortality, the at risk population (denominator) is the ITT population. For the SAE/AE tables, the at risk population (denominator) is the ITT population.
Injury, poisoning and procedural complications Intentional overdose	1.0% 1/100 • Site-Reported Serious Adverse Events (SAE) to 12 Months For All Cause Mortality, the at risk population (denominator) is the ITT population. For the SAE/AE tables, the at risk population (denominator) is the ITT population.
Injury, poisoning and procedural complications Postoperative wound complication	1.0% 1/100 • Site-Reported Serious Adverse Events (SAE) to 12 Months For All Cause Mortality, the at risk population (denominator) is the ITT population. For the SAE/AE tables, the at risk population (denominator) is the ITT population.
Gastrointestinal disorders Colitis ischaemic	1.0% 1/100 • Site-Reported Serious Adverse Events (SAE) to 12 Months For All Cause Mortality, the at risk population (denominator) is the ITT population. For the SAE/AE tables, the at risk population (denominator) is the ITT population.
Gastrointestinal disorders Gastrointestinal haemorrhage	1.0% 1/100 • Site-Reported Serious Adverse Events (SAE) to 12 Months For All Cause Mortality, the at risk population (denominator) is the ITT population. For the SAE/AE tables, the at risk population (denominator) is the ITT population.
Gastrointestinal disorders Haematochezia	1.0% 1/100 • Site-Reported Serious Adverse Events (SAE) to 12 Months For All Cause Mortality, the at risk population (denominator) is the ITT population. For the SAE/AE tables, the at risk population (denominator) is the ITT population.
Gastrointestinal disorders Melaena	1.0% 1/100 • Site-Reported Serious Adverse Events (SAE) to 12 Months For All Cause Mortality, the at risk population (denominator) is the ITT population. For the SAE/AE tables, the at risk population (denominator) is the ITT population.
Gastrointestinal disorders Pancreatitis	1.0% 1/100 • Site-Reported Serious Adverse Events (SAE) to 12 Months For All Cause Mortality, the at risk population (denominator) is the ITT population. For the SAE/AE tables, the at risk population (denominator) is the ITT population.
Gastrointestinal disorders Upper gastrointestinal haemorrhage	1.0% 1/100 • Site-Reported Serious Adverse Events (SAE) to 12 Months For All Cause Mortality, the at risk population (denominator) is the ITT population. For the SAE/AE tables, the at risk population (denominator) is the ITT population.
Nervous system disorders Cerebral haemorrhage	1.0% 1/100 • Site-Reported Serious Adverse Events (SAE) to 12 Months For All Cause Mortality, the at risk population (denominator) is the ITT population. For the SAE/AE tables, the at risk population (denominator) is the ITT population.
Infections and infestations Cellulitis	1.0% 1/100 • Site-Reported Serious Adverse Events (SAE) to 12 Months For All Cause Mortality, the at risk population (denominator) is the ITT population. For the SAE/AE tables, the at risk population (denominator) is the ITT population.
Infections and infestations Lower respiratory tract infection	1.0% 1/100 • Site-Reported Serious Adverse Events (SAE) to 12 Months For All Cause Mortality, the at risk population (denominator) is the ITT population. For the SAE/AE tables, the at risk population (denominator) is the ITT population.
Infections and infestations Upper respiratory tract infection	1.0% 1/100 • Site-Reported Serious Adverse Events (SAE) to 12 Months For All Cause Mortality, the at risk population (denominator) is the ITT population. For the SAE/AE tables, the at risk population (denominator) is the ITT population.
Vascular disorders Orthostatic hypotension	1.0% 1/100 • Site-Reported Serious Adverse Events (SAE) to 12 Months For All Cause Mortality, the at risk population (denominator) is the ITT population. For the SAE/AE tables, the at risk population (denominator) is the ITT population.
Vascular disorders Peripheral arterial occlusive disease	1.0% 1/100 • Site-Reported Serious Adverse Events (SAE) to 12 Months For All Cause Mortality, the at risk population (denominator) is the ITT population. For the SAE/AE tables, the at risk population (denominator) is the ITT population.
Vascular disorders Peripheral ischaemia	1.0% 1/100 • Site-Reported Serious Adverse Events (SAE) to 12 Months For All Cause Mortality, the at risk population (denominator) is the ITT population. For the SAE/AE tables, the at risk population (denominator) is the ITT population.
Blood and lymphatic system disorders Nephrogenic anaemia	1.0% 1/100 • Site-Reported Serious Adverse Events (SAE) to 12 Months For All Cause Mortality, the at risk population (denominator) is the ITT population. For the SAE/AE tables, the at risk population (denominator) is the ITT population.
Respiratory, thoracic and mediastinal disorders Respiratory failure	1.0% 1/100 • Site-Reported Serious Adverse Events (SAE) to 12 Months For All Cause Mortality, the at risk population (denominator) is the ITT population. For the SAE/AE tables, the at risk population (denominator) is the ITT population.

Other adverse events

Other adverse events
Measure	SYNERGY 48 mm n=100 participants at risk SYNERGY 48 mm 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 48 mm: A drug eluting coronary stent system
Cardiac disorders Angina unstable	1.0% 1/100 • Site-Reported Serious Adverse Events (SAE) to 12 Months For All Cause Mortality, the at risk population (denominator) is the ITT population. For the SAE/AE tables, the at risk population (denominator) is the ITT population.
Investigations Blood creatine phosphokinase MB increased	1.0% 1/100 • Site-Reported Serious Adverse Events (SAE) to 12 Months For All Cause Mortality, the at risk population (denominator) is the ITT population. For the SAE/AE tables, the at risk population (denominator) is the ITT population.
Cardiac disorders Coronary artery occlusion	1.0% 1/100 • Site-Reported Serious Adverse Events (SAE) to 12 Months For All Cause Mortality, the at risk population (denominator) is the ITT population. For the SAE/AE tables, the at risk population (denominator) is the ITT population.
Investigations Electrocardiogram T wave abnormal	1.0% 1/100 • Site-Reported Serious Adverse Events (SAE) to 12 Months For All Cause Mortality, the at risk population (denominator) is the ITT population. For the SAE/AE tables, the at risk population (denominator) is the ITT population.

Additional Information

Patricia O'Mara

Boston Scientific

Phone: 518-744-0046

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee A contractual agreement is in place between the PI and the Sponsor that restricts the rights to discuss or publish trial results without prior review by the sponsor.
Publication restrictions are in place

Restriction type: OTHER