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

Peripheral Artery Disease Clinical Trial

— PINTO  

Official title:

A Prospective, Multicenter, Randomized Controlled Trail Using Spot Stenting to Treat Lower Extremity Post-angioplasty Dissection

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05562076
• Other study ID #: 72202207
• Status: Not yet recruiting
• Phase: N/A
• Start date: November 2022
• Est. completion date: February 2025

Study information

• Verified date: September 2022
• Source: Zhejiang Zylox Medical Device Co., Ltd.
• Contact: jie Liang
• Phone: 13819565660
• Email: jie.liang[@]zyloxmedical.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 224
• Est. completion date: February 2025
• Est. primary completion date: February 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Peripheral Arterial Disease
• Peripheral Artery Disease

Intervention

Device:
• the spot stent(ZENFLEX ® Pinto) system
the spot stent(ZENFLEX ® Pinto) system?Color Doppler Ultrasonography (CDU) imaging?Dual Fluoroscopic Imaging?Digital subtraction angiography(DSA)
• the bare stent( Everflex) system
the bare stent( Everflex) system?Color Doppler Ultrasonography (CDU) imaging?Dual Fluoroscopic Imaging?Digital subtraction angiography(DSA)

Locations

Country	Name	City	State
China	Xuanwu Hospital, Capital Medical University	Beijing
China	The First Affiliated Hospital of Bengbu Medical College	Bengbu
China	Changzhou First People's Hospital	Changzhou
China	Changzhou Second People's Hospital	Changzhou
China	The First Affiliated Hospital of Harbin Medical University	Ha'erbin
China	Anhui Provincial Hospital	Hefei
China	The Second Affiliated Hospital of Nanchang University	Nanchang
China	Nanjing Drum Tower Hospital	Nanjing
China	Affiliated Hospital of Qingdao University	Qingdao
China	Shanghai Ninth People's Hospital	Shanghai
China	Tianjin Medical University General Hospital	Tianjin
China	North Jiangsu People's Hospital	Yangzhou

Sponsors (1)

Lead Sponsor	Collaborator
Zhejiang Zylox Medical Device Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	primary patency rate at 12 months after operation		12 months
Secondary	success rate of the device		Intraoperation
Secondary	success rate of the technique		post operation
Secondary	rate of CD-TLR		6 months,12 months
Secondary	ABI		post operation, 6 months,12 months
Secondary	Rutherford classification		post operation, 6 months,12 months
Secondary	the incidence of major adverse events		30 days, 6 months,12 months
Secondary	the rate of target limb major amputation		30 days, 6 months,12 months
Secondary	the incidence of adverse events		Intraoperation, post operation, 30 days, 6 months,12 months
Secondary	the incidence of SAE		Intraoperation, post operation, 30 days, 6 months,12 months
Secondary	the rate of device defect		Intraoperation, 12 months