Last reviewed · How we verify
A Clinical Trial to Assess the SYNERGY 48 mm Stent System for the Treatment of Atherosclerotic Lesion(s)
Phase 3 trial testing SYNERGY 48 mm in Coronary Artery Disease in 100 participants. Completed in 8 January 2021.
| Lead sponsor | Boston Scientific Corporation |
|---|---|
| Phase | Phase 3 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 100 |
| Start date | 12 April 2018 |
| Primary completion | 16 January 2020 |
| Estimated completion | 8 January 2021 |
| Sites | 15 locations across New Zealand, United Kingdom, United States, Latvia |
Boston Scientific Corporation — full company profile →
18 and older, any sex, with Coronary Artery Disease. Patients with the condition only — healthy volunteers not accepted.
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
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.
| Group | Value | 95% CI |
|---|---|---|
| SYNERGY 48 mm | 4 |
The TLR overall rate includes: TLR Percutaneous Coronary Intervention (PCI) and TLR Coronary Artery Bypass Graft (CABG)
| Group | Value | 95% CI |
|---|---|---|
| SYNERGY 48 mm | 1 |
TVR overall includes: TVR PCI and TVR CABG
| Group | Value | 95% CI |
|---|---|---|
| SYNERGY 48 mm | 1 |
Target Vessel Failure is defined as any ischemic-driven revascularization of the target vessel, MI related to the target vessel, or any cardiac death.
| Group | Value | 95% CI |
|---|---|---|
| SYNERGY 48 mm | 4 |
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.
| Group | Value | 95% CI |
|---|---|---|
| SYNERGY 48 mm | 2 |
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.
| Group | Value | 95% CI |
|---|---|---|
| SYNERGY 48 mm | 1 |
Non-cardiac death is defined as a death not due to cardiac causes as previously defined.
| Group | Value | 95% CI |
|---|---|---|
| SYNERGY 48 mm | 4 |
| Group | Value | 95% CI |
|---|---|---|
| SYNERGY 48 mm | 5 |
| Group | Value | 95% CI |
|---|---|---|
| SYNERGY 48 mm | 3 |
| Group | Value | 95% CI |
|---|---|---|
| SYNERGY 48 mm | 6 |
| Group | Value | 95% CI |
|---|---|---|
| SYNERGY 48 mm | 7 |
| Group | Value | 95% CI |
|---|---|---|
| SYNERGY 48 mm | 0 |
Time frame: Site-Reported Serious Adverse Events (SAE) to 12 Months. Reporting threshold: 1%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.
| Reaction | System | SYNERGY 48 mm |
|---|---|---|
| Coronary artery dissection | Cardiac disorders | — |
| Acute kidney injury | Renal and urinary disorders | — |
| Angina pectoris | Cardiac disorders | — |
| Plaque shift | Injury, poisoning and procedural complications | — |
| Carotid artery stenosis | Nervous system disorders | — |
| Acute coronary syndrome | Cardiac disorders | — |
| Cardiac failure congestive | Cardiac disorders | — |
| Colitis | Gastrointestinal disorders | — |
| Osteomyelitis | Infections and infestations | — |
| Intermittent claudication | Vascular disorders | — |
| Haemorrhagic anaemia | Blood and lymphatic system disorders | — |
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | — |
| Non-cardiac chest pain | General disorders | — |
| Bile duct stone | Hepatobiliary disorders | — |
| Fluid overload | Metabolism and nutrition disorders | — |
| Back pain | Musculoskeletal and connective tissue disorders | — |
| Metastases to central nervous system | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | — |
| Anxiety | Psychiatric disorders | — |
| Acute myocardial infarction | Cardiac disorders | — |
| Angina unstable | Cardiac disorders | — |
| Cardiac arrest | Cardiac disorders | — |
| Cardiogenic shock | Cardiac disorders | — |
| Cardiomyopathy | Cardiac disorders | — |
| Chronic left ventricular failure | Cardiac disorders | — |
| Coronary artery disease | Cardiac disorders | — |
| Reaction | System | SYNERGY 48 mm |
|---|---|---|
| Angina unstable | Cardiac disorders | — |
| Blood creatine phosphokinase MB increased | Investigations | — |
| Coronary artery occlusion | Cardiac disorders | — |
| Electrocardiogram T wave abnormal | Investigations | — |
Most-reported serious reactions: Coronary artery dissection, Acute kidney injury, Angina pectoris, Plaque shift, Carotid artery stenosis, Acute coronary syndrome, Cardiac failure congestive, Colitis.
Data from ClinicalTrials.gov NCT03350542 adverse events section.
EVOLVE 48 is a prospective, open label, single arm, multi-center trial. The purpose of this study is to assess the FDA requirement for safety and effectiveness of the SYNERGY 48 mm Coronary Stent System for the treatment of subjects with atherosclerotic lesion(s) \> 34 mm and ≤ 44 mm in length (by visual estimate) in native coronary arteries ≥2.5 mm to ≤4.0 mm in diameter (by visual estimate).
1 peer-reviewed publication reference this trial (live from Europe PMC):
Verify or expand the search:
Trials testing the same drug.
Currently open trials in the same condition.
Trials by the same sponsor.
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03350542.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing