Paclitaxel-coated Balloon for Treatment of De-novo Non-complex Coronary Artery Lesions

NAActive, not recruitingINTERVENTIONAL
Enrollment

2,272

Participants

Timeline

Start Date

February 1, 2021

Primary Completion Date

May 5, 2024

Study Completion Date

May 5, 2027

Conditions
De Novo StenosisCoronary Artery Disease
Interventions
DEVICE

Paclitaxel coated balloon

"The Paclitaxel coated balloon is a paclitaxel-eluting rapid exchange balloon catheter for PTCA. Paclitaxel is the pharmacologically active substance for anti-neointima, whereas iopromide, a well-tolerated nonionic x-ray contrast agent, acts as a release-supporting additive.~The active drug coating is located on the surface of the balloon, which contains 3 μg Paclitaxel per 1 mm2. The spray coating of the mixture of paclitaxel and iopromide of the Swide is via ultrasound, with the crystal size\<2um."

DEVICE

Sirolimus eluting stents

The device has a backbone of L605 cobalt chromium. The stent has a open cell, in-phase, peak-to-valley design. The strut thickness is 86 μm and has a stent profile less than 1.12mm. The polymer coating of the stent is a styrene-butadiene block copolymer. The antiproliferative drug concentration is at 9 ug/mm, which 80% of the drug is released by 30 days.

Trial Locations (1)

710032

Ling Tao, Xi'an

All Listed Sponsors
lead

Xijing Hospital

OTHER