Clinical Study of Focal Implant Used for Lower Extremity Post-angioplasty Dissection (PINTO)

Zhejiang Zylox Medical Device

Status: Not yet enrolling

Conditions: Peripheral Artery Disease

Treatments: Device: the spot stent(ZENFLEX ® Pinto) system; Device: the bare stent( Everflex) system

Study type: Interventional

Funder types: Industry

Identifiers

NCT05562076

72202207

Details and patient eligibility

About

This is a prospective, multicenter, randomized controlled trail using spot stenting to treat lower extremity post-angioplasty dissection.

Enrollment: 224 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

1. Age 18 to 80 years,male or female
2. Lower extremity atherosclerotic occlusive disease
3. After PTA, angiography showed less than 30% residual stenosis of the target lesion (based on visual estimation), and there is one or more dissection(Type A-F)
4. Subjects are able to understand the purpose of the study, demonstrate full compliance with the procedure and follow-up and sign informed consent

Exclusion criteria

1. The target lesion has been stented or previously treated with bypass surgery
2. Acute thrombosis of the target vessel requires thrombolysis or thrombectomy, or has undergone local or systemic thrombolysis within 48 hours
3. Cutting balloon, thrombectomy, plaque resection, brachytherapy, and laser therapy were planned
4. More than 30% residual stenosis of the inflow artery (based on visual estimation) after treatment, or there is no outflow artery in the target limb
5. The target lesion was too calcified to undergo PTA or the guide wire could not pass anterograde through the target lesion
6. Planned amputation on the target limb
7. Severe allergy to anticoagulant drugs, antiplatelet drugs, contrast media and Nitinol
8. Uncontrollable infections
9. Women who are pregnant or breastfeeding, or who plan to become pregnant during the duration of the trial
10. Participating in clinical trials of any other drug or medical device and not yet out of the study
11. Other circumstances not suitable for inclusion as judged by the investigator

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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224 participants in 2 patient groups

ZENFLEX ® Pinto

Experimental group

Description:

subjects using the spot stent(ZENFLEX ® Pinto) system

Treatment:

Device: the spot stent(ZENFLEX ® Pinto) system

Everflex

Active Comparator group

Description:

subjects using the bare stent(Everflex) system

Treatment:

Device: the bare stent( Everflex) system