Combination Therapy of Atherectomy Plus Drug-coated Balloon Versus Drug-coated Balloon for Complex Femoropopliteal Artery Disease

NARecruitingINTERVENTIONAL
Enrollment

300

Participants

Timeline

Start Date

September 15, 2022

Primary Completion Date

June 30, 2029

Study Completion Date

December 31, 2029

Conditions
Femoropopliteal Artery Disease
Interventions
PROCEDURE

Combination therapy of atherectomy and DCB

The target lesion in femoropopliteal artery will be treated with atherectomy folloewd by DCB. The choice of atherectomy devices (HawkOne, Jectstream, or Rotarex)and DCBs (IN.PACT or Ranger) will be left to the operator's decision. In presence of ≥ 50% residual stenosis or flow limiting dissections, implantation of bare nitinol stents is recommended. Implantational of drug-eluting stents is not allowed.

PROCEDURE

DCB alone

The target lesion in femoropopliteal artery will be treated with DCB. The choice of DCBs (IN.PACT or Ranger) will be left to the operator's decision. In presence of ≥ 50% residual stenosis or flow limiting dissections, implantation of bare nitinol stents is recommended. Implantational of drug-eluting stents is not allowed.

Trial Locations (1)

Unknown

RECRUITING

Yonsei University Health System, Severance Hospital, Seoul

All Listed Sponsors
lead

Yonsei University

OTHER