High-Risk PCINCT07010965
SAVE-PCI: NyokAssist™ Small-Bore VAD vs. IABP in Elective High-Risk PCI
A study testing NyokAssist™ and IABP Intra-aortic balloon pump in people with High-Risk PCI, run by magAssist, Inc. at 12 sites in China.
Trial summary
SAVE-PCI 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 intra-aortic balloon pump (IABP) in patients undergoing elective high-risk percutaneous coronary intervention (PCI). Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- High-Risk PCI
- What is being tested?
- NyokAssist™ and IABP Intra-aortic balloon pump
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 236 participants
- Where
- 12 sitesChina
- Study dates
- 31 Jul 2024to 31 Jan 2026
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age eligible (18 ≤ Age ≤ 80)
- 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 .
- Patient presence at least one of the following a or b:
- Intervention on an unprotected left main coronary artery or intervention on the last patent coronary artery .
- Intervention on patient presenting with 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.
- Ejection Fraction ≤40% or Coronary rotational atherectomy or According to the assessment of the cardiac team, PCI requires hemodynamic support .
- Volunteered to participate and Signed Informed Consent and able to cooperate with the whole trial process.
Who cannot join
- Acute ST elevation Myocardial Infarction within 24 hours or CK-MB that have not normalized after acute ST elevation Myocardial Infarction.
- Pre-procedure cardiac arrest within 24 hours of enrollment requiring CPR.
- 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])
- Mural thrombus in the left ventricle.
Show all 23Show fewer
- The presence of aortic valve replacement or mechanical circulatory support device.
- Subject has mechanical complications of myocardial infarction.
- Documented presence of severe aortic stenosis.
- Documented presence of moderate to severe mitral stenosis.
- Documented presence of severe aortic insufficiency.
- Severe peripheral arterial obstructive disease that would preclude device placement.
- Abnormalities of the aorta that would preclude surgery, including aortic aneurysms,aortic dissection and extreme tortuosity or calcifications.
- Subject with renal failure (creatinine ≥265μmol/L)
- Subject with liver dysfunction ( liver enzymes and bilirubin levels ≥3x ULN )
- Subject has uncorrectable abnormal coagulation parameters (platelet count ≤ 75╳109 /L or fibrinogen ≤ 1.50 g/L)
- History of recent (within 1 month) stroke or TIA .
- Severe right ventricular dysfunction,such as severe pulmonary hypertension.
- Allergy or intolerance to heparin, aspirin, ADP receptor inhibitors or contrast media.
- Subject with documented heparin induced thrombocytopenia.
- Subject has pregnant or lactating.
- Participation in the active follow-up phase of another clinical study of an investigational drug or device within 1 month.
- Investigators consider unsuitable to participate in the trial.
Trial locations and contacts
12 sites in 1 country.
12 sites in 1 country
China12 sites
Beijing Anzhen Hospital Capital Medical University
Beijing
The Second Xiangya Hospital of Central South University
Changsha
Guangdong Provincial People's Hospital
Guangzhou
Nanfang Hospital Southern Medical University
Guangzhou
The Second Affiliated Hospital Zhejiang University School of Medicine
Hangzhou
The Second Affiliated Hospital of Harbin Medical University
Harbin
The First Hospital of Lanzhou University
Lanzhou
ZhongShan Hospital Fudan University
Shanghai
Peking University First Hospital Taiyuan Hospital
Taiyuan
The First Affiliated Hospital of Xi'an Jiaotong University
Xi'an
Xiamen Cardiovascular Hospital Xiamen University
Xiamen
Fuwai Yunnan Hospital Chinese Academy of Medical Science
Yunnan
About this study
Official title: SAVE-PCI 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 Intra-aortic Balloon Pump (IABP) in Patients Undergoing Elective High-risk Percutaneous Coronary Intervention (PCI)
SAVE-PCI 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 intra-aortic balloon pump (IABP) in patients undergoing elective high-risk percutaneous coronary intervention (PCI).
- Conditions
- High-Risk PCI
- Being tested
- NyokAssist™, IABP Intra-aortic balloon pump
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NyokAssist™Device
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 .
IABP Intra-aortic balloon pumpDevice
IABP uses counterpulsation to provide coronary flow
| Study group | Role | What they receive |
|---|---|---|
| NyokAssist™ | Experimental | Not described Receives: Device: NyokAssist™ |
| IABP Intra-aortic balloon pump | Active comparator | Not described Receives: Device: IABP Intra-aortic balloon pump |
What is being measured
The primary outcome is the main question the study is designed to answer.
MACCE-free rate
The Major Adverse Cardiovascular and Cerebrovascular Events (MACCE) Free Rate
Measured: Device Delivery through 30 Days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jun 2025
- Study start31 Jul 2024
- Primary completion21 Nov 2025
- Study completion31 Jan 2026 (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
- 236 participants (actual)
Sponsor and investigators
- Lead sponsor
- magAssist, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07010965
- Sponsor's protocol ID
- 2023-133(2)
- Status last verified
- Jun 2025
- First submitted
- 28 May 2025
- Last updated
- 12 Jan 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 12 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- SAVE-PCI 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 Intra-aortic Balloon Pump (IABP) in Patients Undergoing Elective High-risk Percutaneous Coronary Intervention (PCI)
- ClinicalTrials.gov ID
- NCT07010965
- Acronym / sponsor ID
- 2023-133(2)
- Conditions
- High-Risk PCI
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 236 participants (actual)
- Lead sponsor
- magAssist, Inc.Industry (pharma, biotech, devices)
- Study start
- 31 Jul 2024 (actual)
- Primary completion
- 21 Nov 2025 (actual)
- Study completion
- 31 Jan 2026 (estimated)
- First posted
- 8 Jun 2025 (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 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 intra-aortic balloon pump (IABP) 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™ |
| IABP Intra-aortic balloon pump | Active comparator | Device: IABP Intra-aortic balloon pump |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Age eligible (18 ≤ Age ≤ 80)
- 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 .
- Patient presence at least one of the following a or b:
- Ejection Fraction ≤40% or Coronary rotational atherectomy or According to the assessment of the cardiac team, PCI requires hemodynamic support .
- Volunteered to participate and Signed Informed Consent and able to cooperate with the whole trial process.
Key exclusion criteria (23 listed)
- Acute ST elevation Myocardial Infarction within 24 hours or CK-MB that have not normalized after acute ST elevation Myocardial Infarction.
- Pre-procedure cardiac arrest within 24 hours of enrollment requiring CPR.
- Subject is in cardiogenic shock defined as:
- Mural thrombus in the left ventricle.
- The presence of aortic valve replacement or mechanical circulatory support device.
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 |
|---|---|---|
| NyokAssist™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 . | Device | NyokAssist™ |
| IABP Intra-aortic balloon pumpIABP uses counterpulsation to provide coronary flow | Device | IABP Intra-aortic balloon pump |
Primary outcome
MACCE-free rate
Time frame: Device Delivery through 30 Days
The Major Adverse Cardiovascular and Cerebrovascular Events (MACCE) Free Rate
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 12 Jan 2026.
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Pivotal Study of the SUpira System in Patients Undergoing High-Risk Percutaneous COronaRy InTervention (HRPCI)
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ELEVATE High-Risk PCI Pivotal Study
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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)
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SAVE-PCI Ⅱ: NyokAssist™ Small-Bore VAD vs. ECMO in Elective High-Risk PCI
High-risk PCI
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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
12 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 IABP Intra-aortic balloon pump in people with High-Risk PCI, run by magAssist, Inc. at 12 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 8 inclusion and 23 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: under way, not looking for participants, as of the sponsor's last update on 12 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
MACCE-free rate (time frame: Device Delivery through 30 Days). 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 12 Jan 2026.