SAVE-PCI: NyokAssist™ Small-Bore VAD vs. IABP in Elective High-Risk PCI

NCT ID: NCT07010965

Last Updated: 2026-01-12

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 236 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-07-31
• Study Completion Date: 2026-01-31

Brief 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).

Conditions

High-Risk PCI

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

NyokAssist™

Group Type: EXPERIMENTAL

NyokAssist™

Intervention Type: 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 pump

Group Type: ACTIVE_COMPARATOR

IABP Intra-aortic balloon pump

Intervention Type: DEVICE

IABP uses counterpulsation to provide coronary flow

Interventions

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 .

Intervention Type: DEVICE

IABP Intra-aortic balloon pump

IABP uses counterpulsation to provide coronary flow

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

1. Age eligible (18 ≤ Age ≤ 80)

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. Patient presence at least one of the following a or b:

1. Intervention on an unprotected left main coronary artery or intervention on the last patent coronary artery .

2. 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.

4. Ejection Fraction ≤40% or Coronary rotational atherectomy or According to the assessment of the cardiac team, PCI requires hemodynamic support .

5. Volunteered to participate and Signed Informed Consent and able to cooperate with the whole trial process.

Exclusion Criteria

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.

8. Documented presence of moderate to severe mitral stenosis.

9. Documented presence of 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.

12. Subject with renal failure (creatinine ≥265μmol/L)

13. Subject with liver dysfunction ( liver enzymes and bilirubin levels ≥3x ULN )

14. Subject has uncorrectable abnormal coagulation parameters (platelet count ≤ 75╳109 /L or fibrinogen ≤ 1.50 g/L)

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. Subject has pregnant or lactating.

20. Participation in the active follow-up phase of another clinical study of an investigational drug or device within 1 month.

21. Investigators consider unsuitable to participate in the trial.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

magAssist, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Beijing Anzhen Hospital Capital Medical University

Beijing, , China

The Second Xiangya Hospital of Central South University

Changsha, , China

Guangdong Provincial People's Hospital

Guangzhou, , China

Nanfang Hospital Southern Medical University

Guangzhou, , China

The Second Affiliated Hospital Zhejiang University School of Medicine

Hangzhou, , China

The Second Affiliated Hospital of Harbin Medical University

Harbin, , China

The First Hospital of Lanzhou University

Lanzhou, , China

ZhongShan Hospital Fudan University

Shanghai, , China

Peking University First Hospital Taiyuan Hospital

Taiyuan, , China

The First Affiliated Hospital of Xi'an Jiaotong University

Xi'an, , China

Xiamen Cardiovascular Hospital Xiamen University

Xiamen, , China

Fuwai Yunnan Hospital Chinese Academy of Medical Science

Yunnan, , China

Countries

China

Other Identifiers

2023-133(2)

Identifier Type: -

Identifier Source: org_study_id