Effectivity and Safety of PFO Closure vs Medicine in Alleviating Migraine （SPRING）: a Multicenter, Random, Case Control Study

SPRING2021

Effectivity and safety of PFO closure vs medicine in alleviating migraine （SPRING）: a multicenter, random, case control study

2021-08-12

2024-07-01

2025-07-01

Recruiting

Early phase I

440

Inclusion Criteria: 1. Presence of PFO with right-to-left shunt, confirmed by Transthoracic. 2. Echocardiography (TTE) or transesophageal echocardiography (TEE) with a bubble study. 3. Bubble study positive confirmed by transcranial doppler. 4. Subject is diagnosed of migraine. 5. Subject signs an informed Consent Form and is willing to participate in follow-up visits Exclusion Criteria: 1. Subject is diagnosed of headache with clear etiology. 2. Subject had cerebral hemorrhage, bleeding events in other organs within 3 months or was in high risk of bleeding. 3. Brain CT/MR showed ischemic lesions. 4. Subject is diagnosed of hepatic insufficiency: ALT or AST\>3×ULN at the screening visit. 5. Subject is diagnosed of moderate to severe renal insufficiency: eGFR\<30ml/min/1.73m2 at the screening visit. 6. Subject has uncontrolled arrhythmia with clinical significance within 90 days. 7. Subject is diagnosed of unstable angina, severe coronary atherosclerosis or myocardial infarction within 90 days. 8. Subject is diagnosed of pulmonary artery embolism, peripheral artery embolism or deep Vein Thrombosis. 9. Subject cannot follow the study procedure due to other acute or chronic diseases. 10. Subject is pregnant or lactating. 11. Subject is under other RCT. 12. Subject has a life expectancy \<1 year. 13. Subject cannot follow the study procedure due to other reasons in the opinion of the investigators.

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE3'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 440, 'type': 'ESTIMATED'}}

2023-12-19