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

NCT07010965 | Active Not Recruiting

• 1 other identifier: 2023-133(2)
• Study Type: interventional
• Target: 236
• Locations: 1 country
• Sites: 12

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

Outcome Measures

Primary Outcomes (1)

• MACCE-free rate

  The Major Adverse Cardiovascular and Cerebrovascular Events (MACCE) Free Rate

  Device Delivery through 30 Days

Study Arms (2)

NyokAssist™

EXPERIMENTAL

Device: NyokAssist™

IABP Intra-aortic balloon pump

ACTIVE COMPARATOR

Device: IABP Intra-aortic balloon pump

Interventions

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 .

NyokAssist™

IABP Intra-aortic balloon pump DEVICE

IABP uses counterpulsation to provide coronary flow

IABP Intra-aortic balloon pump

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• 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 )

Sponsors & Collaborators

• magAssist, Inc.: lead

Study Sites (12)

Beijing Anzhen Hospital Capital Medical University

Beijing, China

Location

The Second Xiangya Hospital of Central South University

Changsha, China

Location

Guangdong Provincial People's Hospital

Guangzhou, China

Location

Nanfang Hospital Southern Medical University

Guangzhou, China

Location

The Second Affiliated Hospital Zhejiang University School of Medicine

Hangzhou, China

Location

The Second Affiliated Hospital of Harbin Medical University

Harbin, China

Location

The First Hospital of Lanzhou University

Lanzhou, China

Location

ZhongShan Hospital Fudan University

Shanghai, China

Location

Peking University First Hospital Taiyuan Hospital

Taiyuan, China

Location

The First Affiliated Hospital of Xi'an Jiaotong University

Xi'an, China

Location

Xiamen Cardiovascular Hospital Xiamen University

Xiamen, China

Location

Fuwai Yunnan Hospital Chinese Academy of Medical Science

Yunnan, China

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 28, 2025
• First Posted: June 8, 2025
• Study Start: July 31, 2024
• Primary Completion: November 21, 2025
• Study Completion: January 31, 2026
• Last Updated: January 12, 2026

Record last verified: 2025-06

Locations

CN (12)