Active — Not RecruitingPhase 3

Effectivity and Safety of PFO Closure vs Medicine in Alleviating Migraine

China440 participantsStarted 2021-08-12

Plain-language summary

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

Age range16 Years – 60 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. Presence of PFO with right-to-left shunt, confirmed by Transthoracic.
✓. Echocardiography (TTE) or transesophageal echocardiography (TEE) with a bubble study.
✓. Bubble study positive confirmed by transcranial doppler.
✓. Subject is diagnosed of migraine.
✓. Subject signs an informed Consent Form and is willing to participate in follow-up visits

✕. Subject is diagnosed of headache with clear etiology.
✕. Subject had cerebral hemorrhage, bleeding events in other organs within 3 months or was in high risk of bleeding.
✕. Brain CT/MR showed ischemic lesions.
✕. Subject is diagnosed of hepatic insufficiency: ALT or AST\>3×ULN at the screening visit.
✕. Subject is diagnosed of moderate to severe renal insufficiency: eGFR\<30ml/min/1.73m2 at the screening visit.
✕. Subject has uncontrolled arrhythmia with clinical significance within 90 days.
✕. Subject is diagnosed of unstable angina, severe coronary atherosclerosis or myocardial infarction within 90 days.
✕. Subject is diagnosed of pulmonary artery embolism, peripheral artery embolism or deep Vein Thrombosis.

Complete cessation of migraine

Timeframe: Month 12

Serious Adverse Event (SAE) related due to device, drug or study procedure

Timeframe: Month 12

NCT IDNCT04946734

SponsorGuangdong Provincial People's Hospital

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-09-06

Who can participate

Age range16 Years – 60 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. Presence of PFO with right-to-left shunt, confirmed by Transthoracic.
✓. Echocardiography (TTE) or transesophageal echocardiography (TEE) with a bubble study.
✓. Bubble study positive confirmed by transcranial doppler.
✓. Subject is diagnosed of migraine.
✓. Subject signs an informed Consent Form and is willing to participate in follow-up visits

✕. Subject is diagnosed of headache with clear etiology.
✕. Subject had cerebral hemorrhage, bleeding events in other organs within 3 months or was in high risk of bleeding.
✕. Brain CT/MR showed ischemic lesions.
✕. Subject is diagnosed of hepatic insufficiency: ALT or AST\>3×ULN at the screening visit.
✕. Subject is diagnosed of moderate to severe renal insufficiency: eGFR\<30ml/min/1.73m2 at the screening visit.
✕. Subject has uncontrolled arrhythmia with clinical significance within 90 days.
✕. Subject is diagnosed of unstable angina, severe coronary atherosclerosis or myocardial infarction within 90 days.
✕. Subject is diagnosed of pulmonary artery embolism, peripheral artery embolism or deep Vein Thrombosis.