NCT06711822 The Safety and Performence of ShockPulse-10 in Patients with Coronary Artery Calcification
| NCT ID | NCT06711822 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Keya Medical |
| Condition | Coronary Arterial Disease (CAD) |
| Study Type | INTERVENTIONAL |
| Enrollment | 205 participants |
| Start Date | 2024-07-01 |
| Primary Completion | 2025-06-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 205 participants in total. It began in 2024-07-01 with a primary completion date of 2025-06-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
This study is an exploratory, multicenter, single-group clinical trial aimed to evaluate the clinical outcomes of using ShockPulse-10 in the treatment of coronary artery calcification .
Eligibility Criteria
Key Inclusion Criteria: 1. Patient is ≥ 18 years of age; 2. Patients with significant coronary artery disease (including stable or unstable angina and asymptomatic myocardial ischemia) who are suitable for PCI treatment; 3. A single newly developed stenosis of the target vessel, which is the left anterior descending artery, right coronary artery, or circumflex artery (or its branches), with stenosis degree ≥70% or ≥50% (Visually inspect ) and accompanied by evidence of ischemia; 4. The target lesion is a primary, in situ coronary artery lesion; 5. The reference vessel diameter for the target lesion is 2.0-4.0mm, and the length of the target lesion is ≤40mm (Visually inspect); 6. Visual assessment indicates that the lesion site can accommodate the passage of a pre-dilator or trial instrument through the lesion; 7. The target lesion site has moderate to severe calcification (meeting one of the following conditions)： ① Angiography: Moderate calcification :clearer and more easily visible high-density shadows during cardiac pulsation; Severe calcification :clear high-density shadows both during and at rest; ② IVUS calcium score ≥2 points for superficial intimal, deep medial, and mixed calcification; 8. TIMI grade 3 in target vessel before registration (pre-dilation is allowed); Key exclusion Criteria: 1. Left ventricular ejection fraction \< 40%； 2. NYHA class III or IV heart failure； 3. Patients with single coronary artery supply; 4. Patients with evidence of dissection at the site of the lesion on imaging; 5. The imaging suggests that the vascular pathway is tortuous, making it difficult for the pre-dilatation device to reach the target location or to be retrieved; 6. Patients with active systemic infections; 7. Patients with uncontrollable severe hypertension (systolic pressure \> 180 mmHg or diastolic pressure \> 110 mmHg); 8. Patients with coagulopathy, hypercoagulable state or significant bleeding tendency (hemoglobin \<10g/dL or platelet count \<80×10\^9/L);
Contact & Investigator
XIANTAO SONG, Dortor
PRINCIPAL INVESTIGATOR
Beijing Anzhen Hosipital
Frequently Asked Questions
Who can join the NCT06711822 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Coronary Arterial Disease (CAD). Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06711822 currently recruiting?
Yes, NCT06711822 is actively recruiting participants. Contact the research team at Song0929@mail.ccmu.edu.cn for enrollment information.
Where is the NCT06711822 trial being conducted?
This trial is being conducted at Beijing, China.
Who is sponsoring the NCT06711822 clinical trial?
NCT06711822 is sponsored by Keya Medical. The principal investigator is XIANTAO SONG, Dortor at Beijing Anzhen Hosipital. The trial plans to enroll 205 participants.