MAGIC-PAD Trial

JRCT ID: jRCT1020220033

Registered date:29/11/2022

Basic Information

• Recruitment status: Suspended
• Health condition(s) or Problem(s) studied: arteriosclerosis obliterans
• Date of first enrollment: 29/11/2022
• Target sample size: 200
• Study type: Observational

Outcome(s)

• Primary Outcome: Primary patency at 12 & 24 months

Secondary Outcome

1)Minimum lumen diameter
2)Eccentricity index of the target lesion
3)Change in Ankle-Brachial Index before and after EVT
4)Technical success rate of ARCADIA technique
5)Ankle-Brachial Index at 12 and 24 months
6)Rutherford class at 12 and 24 months
7)Procedural complications
8)Procedural time, fluoroscopy time, radiation dose, Contrast volume
9)Minimum lumen diameter by contrast CT at 12 and 24 months (Iliac only)

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

1)18 years of age or older
2)Peripheral artery disease with de novo Iliac/CFA/SFA/PopA eccentric calcified lesion>= 75%
3)Patients with an indication for EVT
4)Patients with accessible medical records throughout the observation term
5)Patients have provided written informed consent

Exclude criteria

1)Inability to provide written informed consent
2) Life expectancy less than 12 months
3)Estimated high risk of non-availability for antiplatelet or anticoagulant medications
4)Patients with other reasons inappropriate for inclusion in the study

Related Information

• Primary Sponsor: Koshida Ryoji