Back to results

ACOART BTK RENEW：A Post Market Clinical Study

Primary Purpose

Peripheral Artery Disease

Status

Recruiting

Phase

Not Applicable

Locations

China

Study Type

Interventional

Intervention

DEB catheter

About this trial

This is an interventional treatment trial for Peripheral Artery Disease

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

1. Age ≥18 years old and ≤75 years old
2. Rutherford clinical category classification：3,4 or 5
3. Significant stenosis (≥70%) or occlusions of de-novo or restenotic lesion(s) located in below-the-knee arteries which distal bloodflow is patent.
4. Reference vessel diameter is between 2 mm and 4 mm
5. Subject has provided written informed consent prior to participation , understands the purpose of this trail and agrees to comply with all protocol-specified examinations and follow-up appointments.

Exclusion Criteria:

1. Plasma creatinine clearance rate <30 mL/min
2. Acute vessel occlusion or acute thrombosis in target lesion
3. Planned amputation on the target limb
4. Subjects confined to bed that are completely non-ambulatory.
5. Thrombolytic therapy or surgical procedure on the target limb within 6 weeks prior to enrollment.
6. Life expectancy < 5 year.
7. Cumulative length of 100% occluded target lesion(s)>150 mm
8. In-stent restenosis within the target lesion, or the distance between the target lesions and the stent was less than 20 mm
9. History of stroke within 90 days prior to enrollment
10. Known allergy to contrast agents, antiplatelet, anticoagulant, or thrombolytic therapy
11. Uncorrectable bleeding diathesis
12. The lesion of the inflow pathway cannot be identified due to the complete occlusion of the P3 segment of the popliteal artery
13. Pregnant or breastfeeding female subjects
14. Ability to cross a guidewire through target lesion
15. Patients who have participated in clinical trials of other medical devices or drugs during the same period

Sites / Locations

Chui Yang Liu Hospital affiliated to Tsinghua UniversityRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

DEB catheter

Arm Description

Use DEB catheter to treat the stenosis or occlusion in below popliteal artery of experimental arm

Outcomes

Primary Outcome Measures

Primary Patency

Primary patency rate is defined as freedom from clinically-driven target lesion revascularisation (CD-TLR) , restenosis as determined by duplex ultrasound (DUS) or digital subtraction angiography (DSA) or major target limb amputation.

Secondary Outcome Measures

Major adverse event (MAE) rate

Defined as a composite rate of all-cause death, target limb major amputation and CD-TLR

Patency rate

Defined as freedom from clinically-driven target lesion revascularisation (CD-TLR) , restenosis as determined by duplex ultrasound (DUS) or digital subtraction angiography (DSA) or major target limb amputation.

Rate of major target limb amputation

A major adverse limb event is defined as above-ankle amputation of the treated limb

Rate of All-cause mortality

All-cause mortality at 12, 24, 36, 48, 60 months post procedure

Rate of clinically-driven target vessel revascularization (CD-TVR)

Clinically-driven target vessel revascularization (CD-TVR) at 12, 24, 36, 48, 60 months post procedure

Rate of clinically-driven target lesion revascularization (CD-TLR)

Clinically-driven target lesion revascularization (CD-TLR) at 12, 24, 36, 48, 60 months post procedure

Rate of ulcer healing

Ulcer healed or not; if not, improving, stagnant,worsening

Rate of distal embolization

Rate of distal embolization defined as occurrence significant distal embolization in target limb through the end of the procedure

Full Information

NCT ID

NCT04885985

First Posted

May 10, 2021

Last Updated

May 28, 2023

Sponsor

Acotec Scientific Co., Ltd

1. Study Identification

Unique Protocol Identification Number

NCT04885985

Brief Title

ACOART BTK RENEW：A Post Market Clinical Study

Official Title

A Post Market Clinical Study to Evaluate the Safety and Efficacy of the Acotec Drug-coated Balloon in the Treatment of the Below-the-knee Artery

Study Type

Interventional

2. Study Status

Record Verification Date

May 2023

Overall Recruitment Status

Recruiting

Study Start Date

December 31, 2021 (Actual)

Primary Completion Date

August 1, 2024 (Anticipated)

Study Completion Date

April 1, 2027 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Acotec Scientific Co., Ltd

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

5. Study Description

Brief Summary

The objective of this prospective, multi-center, single arm study is to obtain further data on the safety and performance of the Acotec Litos&Tulip Drug-coated Balloon catheters in the treatment of lesions in below-the-knee artery.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Peripheral Artery Disease

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

107 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

DEB catheter

Arm Type

Experimental

Arm Description

Use DEB catheter to treat the stenosis or occlusion in below popliteal artery of experimental arm

Intervention Type

Device

Intervention Name(s)

DEB catheter

Intervention Description

Trade name of DEB catheter: AcoArt Tulip (0.018") or AcoArt Litos (0.014")

Primary Outcome Measure Information:

Title

Primary Patency

Description

Time Frame

6 month

Secondary Outcome Measure Information:

Title

Major adverse event (MAE) rate

Description

Defined as a composite rate of all-cause death, target limb major amputation and CD-TLR

Time Frame

30 days

Title

Patency rate

Description

Time Frame