Phase 3
Completed N=100
A Clinical Trial to Assess the SYNERGY 48 mm Stent System for the Treatment of Atherosclerotic Lesion(s)
Source: ClinicalTrials.gov NCT03350542 ↗Enrolled (actual)
100
Serious AEs
31.0%
Results posted
Feb 2021
Primary outcomePrimary: Target Lesion Failure Rate at 12-months — 4 percentage of participants
◆ Published Evidence
No publication linked
No peer-reviewed publication reporting this trial's results has been linked yet. This can indicate results are unpublished — a known publication-bias signal. We re-check periodically.
Summary
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).
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Target Lesion Failure Rate at 12-months |
4 | — |
| SECONDARY Target Lesion Revascularization (TLR) Rate at 12 Months |
1 | — |
| SECONDARY Target Vessel Revascularization (TVR) Rate at 12 Months. |
1 | — |
| SECONDARY Target Vessel Failure (TVF) Rate at 12 Months |
4 | — |
| SECONDARY MI (Q-wave and Non-Q-wave) Rate |
2 | — |
| SECONDARY Cardiac Death Rate |
1 | — |
| SECONDARY Non-cardiac Death Rate |
4 | — |
| SECONDARY All Death Rate |
5 | — |
| SECONDARY Cardiac Death or MI Rate |
3 | — |
| SECONDARY All Death or MI Rate |
6 | — |
| SECONDARY All Death/MI/TVR Rate |
7 | — |
| SECONDARY Stent Thrombosis Rate |
— | — |
| SECONDARY Periprocedural Technical Success Rate |
100 | — |
| SECONDARY Periprocedural Clinical Procedural Success Rate |
100 | — |
Eligibility Criteria
Clinical Inclusion Criteria
- Subject must be at least 18 years of age
- Subject (or legal guardian) understands the trial requirements and the treatment procedures and provides written informed consent before any trial-specific tests or procedures are performed
- Subject is eligible for percutaneous coronary intervention (PCI) and is an acceptable candidate for coronary artery bypass grafting (CABG)
- Subject has either:
- Symptomatic coronary artery disease with one of the following: stenosis ≥ 70%, abnormal fractional flow reserve (FFR), abnormal stress or imaging stress test, or elevated biomarkers prior to the procedure
- OR
- Documented silent ischemia based on one of the following: abnormal fractional flow reserve (FFR), abnormal stress or imaging stress test, or elevated biomarkers prior to the procedure
- Subject is willing to comply with all protocol-required follow-up evaluation Angiographic Inclusion Criteria (visual estimate)
- Target lesion must be located in a native coronary artery with a visually estimated reference vessel diameter (RVD) ≥2.5 mm and ≤4.0 mm
- Target lesion length must be >34 mm and ≤44 mm (by visual estimate)
- Target lesion must have visually estimated stenosis ≥50% and 1
- Coronary anatomy is likely to allow delivery of a study device to the target lesion
- The target lesion must be successfully predilated/pretreated. If a non-target lesion is treated, it should be treated first and should be deemed an angiographic success Note: Angiographic success is a mean lesion diameter stenosis 700,000 cells/mm3
- Subject has a white blood cell (WBC) count 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 signs or symptoms of active heart failure (i.e., New York Heart Association (NYHA) class IV) at the time of the index procedure
- 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 Angiographic Exclusion Criteria (visual estimate)
- Subject has more than 1 target lesion, or more than 1 target lesion and 1 non-target lesion, which will be treated during the index procedure Note: Multiple focal stenoses will be considered as a single lesion if they can be completely covered with 1 study stent
- Treatment of lesions in more than 2 major epicardial vessels Note: 1 target lesion in the target vessel and 1 non-target lesion in non-target vessel is allowed
- Subject has unprotected left main coronary artery disease (>50% diameter stenosis)
- Subject has been treated with any type of PCI (i.e., balloon angioplasty, stent, cutting balloon atherectomy) within 24 hours prior to the index procedure
- Thrombus, or possible thrombus, present in the target vessel (by visual estimate)
- Target lesion meets any of the following criteria:
- Treatment of a single lesion with more than 1 stent
- Left main location
- Lesion is located within 3 mm of the origin of the left anterior descending (LAD) coronary artery or left circumflex (LCx) coronary artery by visual estimate
- Lesion is located within a saphenous vein graft or an arterial graft
- Lesion will be accessed via a saphenous vein graft or arterial graft
- Lesion with a TIMI flow 0 (total occlusion) or TIMI flow 1 prior to guide wire crossing
- Lesion treated during the in
Data sourced from ClinicalTrials.gov (NCT03350542). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.