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New treatment option for High-Risk Percutaneous Coronary Intervention (High-risk PCI)
Official title Interventional Left Ventricular Assist System for PCI in CHIP Patients
ClinicalTrials.gov ID: NCT07053618
What this study is testing
- What it's testing
- Mechanical circulatory support (MCS) is a life-sustaining therapy first introduced in the 1950s. After six decades of development, it now serves as a critical bridge therapy for patients with acute cardiac events and end-stage heart failure.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 90
You may be able to join if
- 1\. Aged 18-90 2. The investigator assesses that the subject requires coronary revascularization, but CABG (Coronary Artery Bypass Grafting) is...
- Unprotected left main (LM) coronary artery disease (coronary stenosis ≥ 50%).
- A last remaining patent coronary artery (the anterior descending artery (LAD) and/or its branches, the circumflex artery (LCX) and/or its branches...
- Saphenous vein graft (SVG) vascular lesions.
- Severely calcification, tortuosity.
You likely can't join if
- Cardiogenic shock (CS) within 7 days (Cardiogenic shock: Sustained SBP \ 90 mmHg and end-organ hypoperfusion (urine output \<30 ml/h or cool...
- STEMI or CK-MB did not return to the normal range within 24 hours.
- Cardiac arrest with cardiopulmonary resuscitation within 24 hours.
- Left ventricular mural thrombus.
- After aortic valve replacement surgery (mechanical, bioprosthetic).
- Having used or using ECMO or pVAD (percutaneous ventricular assist device) within 7 days.
See the full eligibility criteria
- 1\. Aged 18-90 2. The investigator assesses that the subject requires coronary revascularization, but CABG (Coronary Artery Bypass Grafting) is considered high-risk or the subject refuses CABG. The investigator believes...
- Unprotected left main (LM) coronary artery disease (coronary stenosis ≥ 50%).
- A last remaining patent coronary artery (the anterior descending artery (LAD) and/or its branches, the circumflex artery (LCX) and/or its branches, and the right coronary artery (RCA) and/or its branches).
- Saphenous vein graft (SVG) vascular lesions.
- Severely calcification, tortuosity.
- Multivessel disease (two or more) combined with chronic total occlusion (CTO).
- Three-vessel disease. Three-vessel disease is defined as significant stenosis (≥ 70%) in at least one segment of all three major epicardial coronary artery territories: the left anterior descending artery (LAD) and/or...
- Cardiogenic shock (CS) within 7 days (Cardiogenic shock: Sustained SBP \ 90 mmHg and end-organ hypoperfusion (urine output \<30 ml/h or cool extremities).
- STEMI or CK-MB did not return to the normal range within 24 hours.
- Cardiac arrest with cardiopulmonary resuscitation within 24 hours.
- Left ventricular mural thrombus.
- After aortic valve replacement surgery (mechanical, bioprosthetic).
- Having used or using ECMO or pVAD (percutaneous ventricular assist device) within 7 days.
- Moderate to severe aortic stenosis, moderate to severe aortic valve insufficiency.
- Atrial septal or ventricular septal defects (including post-infarction VSD), or post-myocardial infarction Free-Wall Rupture, or papillary muscle rupture.
- Severe right heart failure or severe tricuspid valve insufficiency.
- Disease or abnormality of the aorta that interferes with the procedure, including Marfan syndrome, coarctation of aortic, aortic aneurysm, severe tortuosity or calcification of the aorta.
- Severe peripheral arterial stenosis or occlusive lesions.
- Uncorrectable moderate or severe anemia prior to the procedure (hemoglobin \<90 g/L). Abnormal coagulation function (routine blood test indicates platelet count less than 75×109/L, INR ≥2.0, or fibrinogen ≤1.5 g/L).
- Known contraindications to heparin, contrast agents, or study-required medications (e.g., aspirin, clopidogrel); history of Heparin-induced thrombocytopenia.
- Active hemorrhage within 1 month.
- History of stroke or TIA or permanent neurologic deficits within one month prior to the procedure.
- Renal dysfunction: subject on dialysis or serum creatinine ≥4 mg/dL (353.6 µmol/L) within 7 days.
- Liver dysfunction: liver AST, ALT and bilirubin \>3 times the upper limit of normal within 7 days.
- Presence or suspected presence of infective endocarditis or systemic infection.
- Women who are pregnant, breastfeeding, or planning pregnancy during the trial.
- Participation in another drug or medical device clinical trial.
- Other conditions deemed by the investigator as unsuitable for participation in this trial. \-
The study team makes the final eligibility decision.
Where it's taking place
- Beijing, Beijing Municipality, China
- Xiamen, Fujian, China
- Lanzhou, Gansu, China
- Guangzhou, Guangdong, China
- Zhengzhou, Henan, China
- Changsha, Hunan, China
- Suzhou, Jiangsu, China
- Nanchang, Jiangxi, China
- Shenyang, Liaining, China
- Hangzhou, Zhejiang, China
- Ningbo, Zhejiang, China
- Wenzhou, Zhejiang, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 90 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Beijing, Beijing Municipality, China; Xiamen, Fujian, China; Lanzhou, Gansu, China; Guangzhou, Guangdong, China; Zhengzhou, Henan, China; Changsha, Hunan, China and 6 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.