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

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

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

Study Overview

• Status: Not yet recruiting
• Conditions: Peripheral Artery Disease
• Intervention / Treatment: Device: the spot stent(ZENFLEX ® Pinto) system; Device: the bare stent( Everflex) system

• Study Type: Interventional
• Enrollment (Anticipated): 224
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Beijing, China
    • Xuanwu Hospital, Capital Medical University
    • Contact: Lianrui Guo
  • Bengbu, China
    • The First Affiliated Hospital of Bengbu Medical College
    • Contact: Chaowen Yu
  • Changzhou, China
    • Changzhou Second People's Hospital
    • Contact: Yunfeng Zhu
  • Changzhou, China
    • Changzhou First People's Hospital
    • Contact: Yufeng Zhu
  • Ha'erbin, China
    • The First Affiliated Hospital of Harbin Medical University
    • Contact: Bing Liu
  • Hefei, China
    • Anhui Provincial Hospital
  • Nanchang, China
    • The Second Affiliated Hospital of Nanchang University
    • Contact: Weimin Zhou
  • Nanjing, China
    • Nanjing Drum Tower Hospital
    • Contact: Xiaoqiang Li
  • Qingdao, China
    • Affiliated Hospital of Qingdao University
    • Contact: Mingjin Guo
  • Shanghai, China
    • Shanghai Ninth People's Hospital
  • Tianjin, China
    • Tianjin Medical University General Hospital
  • Yangzhou, China
    • North Jiangsu People's Hospital
    • Contact: Zhaolei Chen

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: ZENFLEX ® Pinto; subjects using the spot stent(ZENFLEX ® Pinto) system	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）
Active Comparator: Everflex; subjects using the bare stent(Everflex) system	Device: the bare stent( Everflex) system; the bare stent( Everflex) system、Color Doppler Ultrasonography (CDU) imaging、Dual Fluoroscopic Imaging、Digital subtraction angiography（DSA）

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
primary patency rate at 12 months after operation	12 months

Secondary Outcome Measures

Outcome Measure	Time Frame
success rate of the device	Intraoperation
success rate of the technique	post operation
rate of CD-TLR	6 months,12 months
ABI	post operation, 6 months,12 months
Rutherford classification	post operation, 6 months,12 months
the incidence of major adverse events	30 days, 6 months,12 months
the rate of target limb major amputation	30 days, 6 months,12 months
the incidence of adverse events	Intraoperation, post operation, 30 days, 6 months,12 months
the incidence of SAE	Intraoperation, post operation, 30 days, 6 months,12 months
the rate of device defect	Intraoperation, 12 months

Collaborators and Investigators

• Sponsor: Zhejiang Zylox Medical Device Co., Ltd.
• Investigators: Principal Investigator: Xiaoqiang Li, The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

Study record dates

Study Major Dates

• Study Start (Anticipated): November 1, 2022
• Primary Completion (Anticipated): February 1, 2024
• Study Completion (Anticipated): February 1, 2025

Study Registration Dates

• First Submitted: August 15, 2022
• First Submitted That Met QC Criteria: September 27, 2022
• First Posted (Actual): September 30, 2022

Study Record Updates

• Last Update Posted (Actual): September 30, 2022
• Last Update Submitted That Met QC Criteria: September 27, 2022
• Last Verified: September 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Atherosclerosis; Peripheral Vascular Diseases; Peripheral Arterial Disease
• Other Study ID Numbers: 72202207

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No