High-risk PCINCT07860671
SAVE-PCI Ⅱ: NyokAssist™ Small-Bore VAD vs. ECMO in Elective High-Risk PCI
A study testing NyokAssist and ECMO in people with High-risk PCI, run by magAssist, Inc. at 14 sites in China.
Trial summary
SAVE-PCI Ⅱ is a prospective, multi-center, randomized controlled trial evaluating the safety and efficacy of NyokAssist™, a small-bore percutaneous ventricular assist device (pVAD), in comparison with ECMO in patients undergoing elective high-risk percutaneous coronary intervention (PCI). Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- High-risk PCI
- What is being tested?
- NyokAssist and ECMO
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 204 participants
- Where
- 14 sitesChina
- Study dates
- 9 Apr 2026to 31 Mar 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 1. Age eligible (18 ≤ Age ≤ 90). 2. Subject is indicated for a non-emergent percutaneous treatment of at least one de novo or restenotic lesion in a native coronary vessel or bypass graft .
- 3. The subjects' left ventricular ejection fraction (LVEF) and imaging results met both of the following a and b :
- LVEF ≤ 35%; or LVEF ≤ 40% with NYHA functional class ≥ III.
- Imaging criteria:
- Chronic total occlusion (CTO) in at least two vessels; or No unprotected left main coronary artery lesion; or Three-vessel disease.
- Three-vessel disease was defined as the presence at least one sign ficant stenosis ≥ 50% in the left anterior descending artery (LAD) and/or side branch, left circumflex artery (LCX) and/or side branch, and right coronary artery (RCA) and/or side branch. In the case of left coronary artery dominance, a lesion ≥ 50% in the proximal LAD and the LCX qualified as three-vessel disease.
- 5.Volunteered to participate and Signed Informed Consent and able to cooperate with the whole trial process.
Who cannot join
- 1.Acute ST elevation Myocardial Infarction within 24 hours or CK-MB that have not normalized after acute ST elevation Myocardial Infarction.
- 2.Pre-procedure cardiac arrest within 24 hours of enrollment requiring CPR. 3.Subject is in cardiogenic shock defined as:
- CI < 2.2 L/min/m2 and PCWP > 15 mmH
- Hypotension (systolic BP < 90 mmHg for >30 minutes or the need for supportive measures to maintain a systolic BP of greater than or equal to 90 mmHg) AND end organ hypoperfusion (cool extremities OR [a urine output of < 30 mL/hour AND a HR > 60 BPM]) 4.Mural thrombus in the left ventricle. 5.The presence of aortic valve replacement or mechanical circulatory support device. 6.Subject has mechanical complications of myocardial infarction.
- 7.Documented presence of severe aortic stenosis. aortic valve area (AVA) ≤ 1.0 cm².
- 8.Documented presence of moderate to severe mitral stenosis. 9.Documented presence of moderate to severe aortic insufficiency. 10.Severe peripheral arterial obstructive disease that would preclude device placement.
Show all 13Show fewer
- 11.Abnormalities of the aorta that would preclude surgery, including aortic aneurysms,aortic dissection and extreme tortuosity or calcifications.
- 12.Subject with renal failure (creatinine ≥265μmol/L) . 13.Subject with liver dysfunction ( liver enzymes and bilirubin levels ≥3x URL or INR≥2 ).
- 14.Subject has uncorrectable abnormal coagulation parameters (platelet count ≤ 75╳109 /L or fibrinogen ≤ 1.50 g/L or INR≥2) .
- 15.History of recent (within 1 month) stroke or TIA . 16.Severe right ventricular dysfunction,such as severe pulmonary hypertension. 17.Allergy or intolerance to heparin, aspirin, ADP receptor inhibitors or contrast media.
- 18.Subject with documented heparin induced thrombocytopenia. 19.Atrial or ventricular septal defect (including post-infarction ventricular septal rupture).
- 20.Subject has pregnant or lactating. 21.Participation in the active follow-up phase of another clinical study of an investigational drug or device within 1 month.
- 22.Investigators consider unsuitable to participate in the trial.
Trial locations and contacts
14 sites in 1 country. Contact the study team or a site near you to ask about taking part.
14 sites in 1 country
China14 sites, 14 recruiting
- Recruiting
Luhe Hospital, Capital Medical University
Beijing
Zhai Guangyao
- Recruiting
The Second Xiangya Hospital of Central South University
Changsha
Fang Zhenfei
- Recruiting
Guangdong Provincial People's Hospital
Guangzhou
Jing Zhicheng
- Recruiting
Nanfang Hospital Southern Medical University
Guangzhou
Xiu Jiancheng
- Recruiting
The First Affiliated Hospital of Jinan University
Guangzhou
Guo Jun
- Recruiting
The Second Affiliated Hospital of Nanchang University
Nanchang
Yang Renqiang
- Recruiting
ZhongShan Hospital Fudan University
Shanghai
Ge Junbo
- Recruiting
The First Hospital of China Medical University
Shenyang
Sun Yingxian
- Recruiting
The Second Affiliated Hospital of Soochow University
Suzhou
Li Hun
- Recruiting
Tangdu Hospital of Air Force Military Medical University
Xi'an
Li Yan
- Recruiting
The First Affiliated Hospital of Xi'an Jiaotong University
Xi'an
Yuan Zuyi
- Recruiting
Xiamen Cardiovascular Hospital Xiamen University
Xiamen
Wang Yan
- Recruiting
Fu Wai Central China Cardiovascular Hospital
Zhengzhou
Ye Faming
- Recruiting
The 7th People's Hospital of Zhengzhou
Zhengzhou
Li Jing
About this study
Official title: A Prospective, Multi-center, Randomized Controlled, Non-Inferiority Trial to Evaluate the Safety and Efficacy of a Percutaneous Ventricular Assist Device
SAVE-PCI Ⅱ is a prospective, multi-center, randomized controlled trial evaluating the safety and efficacy of NyokAssist™, a small-bore percutaneous ventricular assist device (pVAD), in comparison with ECMO in patients undergoing elective high-risk percutaneous coronary intervention (PCI).
- Conditions
- High-risk PCI
- Being tested
- NyokAssist, ECMO
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NyokAssistDevice
The NyokAssist™ Ventricular Assist Device can be placed across the aortic valve using a single femoral site. The device pumps blood from the left ventricle into the ascending aorta .
ECMODevice
Extracorporeal Membrane Oxygenation provides extracorporeal gas exchange through use of a membrane oxygenator. Blood is drained from a central vein and returned after oxygenation into the arterial circulation .
| Study group | Role | What they receive |
|---|---|---|
| NyokAssist™ | Experimental | Not described Receives: Device: NyokAssist |
| ECMO | Active comparator | Not described Receives: Device: ECMO |
What is being measured
The primary outcome is the main question the study is designed to answer.
30-day MAE rate after randomization
The major adverse events are defined as:
Death. Stroke. Myocardial infarction. Revascularization. Rehospitalization due to cardiovascular reasons. Type 3, 4, and 5 bleeding (as defined by MCS-ARC). Acute kidney injury. Severe device-related adverse events. Cardiopulmonary resuscitation.
Measured: 30-day after randomization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Oct 2026
- Study start9 Apr 2026
- Primary completion31 Jan 2027 (estimated)
- Study completion31 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for High-risk PCIStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 204 participants (estimated)
Sponsor and investigators
- Lead sponsor
- magAssist, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07860671
- Sponsor's protocol ID
- 2026-004R
- Status last verified
- Sep 2026
- First submitted
- 30 Sep 2026
- Last updated
- 6 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Multi-center, Randomized Controlled, Non-Inferiority Trial to Evaluate the Safety and Efficacy of a Percutaneous Ventricular Assist Device
- ClinicalTrials.gov ID
- NCT07860671
- Acronym / sponsor ID
- 2026-004R
- Conditions
- High-risk PCI
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 204 participants (estimated)
- Lead sponsor
- magAssist, Inc.Industry (pharma, biotech, devices)
- Study start
- 9 Apr 2026 (actual)
- Primary completion
- 31 Jan 2027 (estimated)
- Study completion
- 31 Mar 2027 (estimated)
- First posted
- 6 Oct 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
SAVE-PCI Ⅱ is a prospective, multi-center, randomized controlled trial evaluating the safety and efficacy of NyokAssist™, a small-bore percutaneous ventricular assist device (pVAD), in comparison with ECMO in patients undergoing elective high-risk percutaneous coronary intervention (PCI).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| NyokAssist™ | Experimental | Device: NyokAssist |
| ECMO | Active comparator | Device: ECMO |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 1. Age eligible (18 ≤ Age ≤ 90). 2. Subject is indicated for a non-emergent percutaneous treatment of at least one de novo or restenotic lesion in a native coronary vessel or bypass graft .
- 3. The subjects' left ventricular ejection fraction (LVEF) and imaging results met both of the following a and b :
- LVEF ≤ 35%; or LVEF ≤ 40% with NYHA functional class ≥ III.
- Imaging criteria:
- Chronic total occlusion (CTO) in at least two vessels; or No unprotected left main coronary artery lesion; or Three-vessel disease.
Key exclusion criteria (13 listed)
- 1.Acute ST elevation Myocardial Infarction within 24 hours or CK-MB that have not normalized after acute ST elevation Myocardial Infarction.
- 2.Pre-procedure cardiac arrest within 24 hours of enrollment requiring CPR. 3.Subject is in cardiogenic shock defined as:
- 7.Documented presence of severe aortic stenosis. aortic valve area (AVA) ≤ 1.0 cm².
- 8.Documented presence of moderate to severe mitral stenosis. 9.Documented presence of moderate to severe aortic insufficiency. 10.Severe peripheral arterial obstructive disease that would preclude device placement.
- 11.Abnormalities of the aorta that would preclude surgery, including aortic aneurysms,aortic dissection and extreme tortuosity or calcifications.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NyokAssistThe NyokAssist™ Ventricular Assist Device can be placed across the aortic valve using a single femoral site. The device pumps blood from the left ventricle into the ascending aorta . | Device | NyokAssist™ |
| ECMOExtracorporeal Membrane Oxygenation provides extracorporeal gas exchange through use of a membrane oxygenator. Blood is drained from a central vein and returned after oxygenation into the arterial circulation . | Device | ECMO |
Primary outcome
30-day MAE rate after randomization
Time frame: 30-day after randomization
The major adverse events are defined as: Death. Stroke. Myocardial infarction. Revascularization. Rehospitalization due to cardiovascular reasons. Type 3, 4, and 5 bleeding (as defined by MCS-ARC). Acute kidney injury. Severe device-related adverse events. Cardiopulmonary resuscitation.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Oct 2026.
Related trials for High-risk PCI
Not yet recruiting
Hs-CRP-Guided Colchicine Treatment Targets in Very-High-Risk Patients With Coronary Artery Disease After PCI (TARGET-CHD)
Coronary Artery Disease, Atherosclerotic Cardiovascular Disease (ASCVD)
Recruiting
Pivotal Study of the SUpira System in Patients Undergoing High-Risk Percutaneous COronaRy InTervention (HRPCI)
Coronary Artery Disease, High Risk Percutaneous Coronary Intervention
Recruiting
ELEVATE High-Risk PCI Pivotal Study
High-Risk Percutaneous Coronary Intervention (High-risk PCI)
RecruitingPhase 4
Dual Antiplatelet Therapy Escalation From Standard-dose Clopidogrel to Low-Dose Prasugrel in Patients With High Bleeding and Ischemic Risk Undergoing PCI: A Prospective, Randomized Pharmacodynamic Study (TAILOR-BLEED-2)
Coronary Arterial Disease (CAD), Percutaneous Coronary Intervention (PCI)
RecruitingObservational study
IVUS CHIP UPP Registry
Coronary Artery Disease, Coronary Artery Disease Risk High
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
14 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing NyokAssist and ECMO in people with High-risk PCI, run by magAssist, Inc. at 14 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 6 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 14 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact YE (+86-18662176199, beibei.ye@magassist.tech), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
30-day MAE rate after randomization (time frame: 30-day after randomization). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Oct 2026.