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First-in-man Study of Titanium-Nitride Coated Woven-nitinol Peripheral Arterial Stent

Primary Purpose

Peripheral Arterial Disease

Status

Completed

Phase

Not Applicable

Locations

Hong Kong

Study Type

Interventional

Intervention

GoldenFlow Stent

About this trial

This is an interventional treatment trial for Peripheral Arterial Disease focused on measuring femoropopliteal disease, restenosis

Eligibility Criteria

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

Inclusion Criteria:

Age ≥18 years
Symptomatic leg ischemia (Rutherford class 2 to 4)
Ankle Brachial Index <0.9
De novo femoropopliteal stenosis (≥70%) or occlusion
Reference diameter 4 and 7mm
Lesion length 4 to 15cm
At least one patent (<50% stenosis) infrapopliteal run-off vessel
The lesion(s) can be successfully crossed with a guidewire and dilated
Patients with bilateral femoropopliteal disease is eligible for enrollment into the study
- Staged contralateral limb procedure can be performed >30 days after index procedure
Able to provide written informed consent and willing to comply with specified follow-up evaluation schedule

Exclusion Criteria:

Tissue loss or gangrene (Rutherford class 5 and 6)
Previous bypass surgery or stenting in target vessel
Untreated aortoiliac or common femoral artery inflow disease >50%
Intervention of ipsilateral lesions during the index procedure or staged intervention within 30 days after index procedure

Sites / Locations

Prince of Wales Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

GoldenFlow stent

Arm Description

Titanium nitrite coated woven nitinol stent

Outcomes

Primary Outcome Measures

In-stent binary restenosis of the treated segment

Determined by Duplex ultrasound

Secondary Outcome Measures

Technical Success

defined as residual diameter stenosis <30%

Safety Outcomes as assessed by composite of death, index limb amputation and ischemic driven target vessel revacularization

Composite of death, index limb amputation and ischemic driven target vessel revacularization at 30 days

Clinically driven target vessel revascularization

Stent fracture

defined by plain x-ray

Full Information

NCT ID

NCT02499510

First Posted

May 11, 2015

Last Updated

July 26, 2019

Sponsor

Chinese University of Hong Kong

Collaborators

Lifetech Scientific (Shenzhen) Co., Ltd.

1. Study Identification

Unique Protocol Identification Number

NCT02499510

Brief Title

First-in-man Study of Titanium-Nitride Coated Woven-nitinol Peripheral Arterial Stent

Official Title

First-in-man Study to Assess Efficacy and Safety of a Novel Titanium-Nitride Coated Woven-nitinol Peripheral Arterial Stent

Study Type

Interventional

2. Study Status

Record Verification Date

July 2019

Overall Recruitment Status

Completed

Study Start Date

October 2015 (undefined)

Primary Completion Date

November 2017 (Actual)

Study Completion Date

May 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Chinese University of Hong Kong

Collaborators

Lifetech Scientific (Shenzhen) Co., Ltd.

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

The GoldenFlow (Lifetech Scientific, Shenzhen, China) is a novel woven-nitinol stent designed to have superior radial strength, flexibility and durability compared to standard nitinol stents for femoropopliteal lesions. This is a first-in-man study to evaluate the safety and efficacy of GoldenFlow woven-nitinol stent for intraluminal treatment of peripheral vascular disease in the femoropopliteal arteries.

Detailed Description

Endovascular treatment in femoropopliteal segment is the most challenging area due to restenosis and stent fracture after endovascular treatment. The titanium-nitride coated woven-nitinol peripheral arterial stent system (GoldenFlow, Lifetech Science, Shenzhen, China) is designed to have superior radial strength, flexibility and durability to withstand the compression, torsion, bending, lengthening and shortening found in femoropopliteal disease. Compared to another commercially available woven-nitinol stent, the GoldenFlow stent has the potential advantage to be repositionable and is less likely to lengthen during deployment. This is a first-in-man study is to evaluate the safety and efficacy of GoldenFlow woven-nitinol stent for intraluminal treatment of peripheral vascular disease in de-novo femoropopliteal lesions.

6. Conditions and Keywords

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

Peripheral Arterial Disease

Keywords

femoropopliteal disease, restenosis

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

5 (Actual)

8. Arms, Groups, and Interventions

Arm Title

GoldenFlow stent

Arm Type

Experimental

Arm Description

Titanium nitrite coated woven nitinol stent

Intervention Type

Device

Intervention Name(s)

GoldenFlow Stent

Other Intervention Name(s)

Titanium-nitride coated GoldenFlow woven-nitinol stent

Intervention Description

The GoldenFlow stent (Lifetech Science, Shenzhen, China) is a TiN coated self-expanding stent consisting of interwoven nitinol wires braided in a closed cell design. Stents used in this study ranged from 4-12mm in diameter and 20-160mm in length.

Primary Outcome Measure Information:

Title

In-stent binary restenosis of the treated segment

Description

Determined by Duplex ultrasound

Time Frame

at 6 month

Secondary Outcome Measure Information:

Title

Technical Success

Description

defined as residual diameter stenosis <30%

Time Frame

intraoperation

Title

Safety Outcomes as assessed by composite of death, index limb amputation and ischemic driven target vessel revacularization

Description

Composite of death, index limb amputation and ischemic driven target vessel revacularization at 30 days

Time Frame

30 days

Title

Clinically driven target vessel revascularization

Time Frame

6 months

Title

Stent fracture

Description

defined by plain x-ray

Time Frame

6 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Age ≥18 years Symptomatic leg ischemia (Rutherford class 2 to 4) Ankle Brachial Index <0.9 De novo femoropopliteal stenosis (≥70%) or occlusion Reference diameter 4 and 7mm Lesion length 4 to 15cm At least one patent (<50% stenosis) infrapopliteal run-off vessel The lesion(s) can be successfully crossed with a guidewire and dilated Patients with bilateral femoropopliteal disease is eligible for enrollment into the study - Staged contralateral limb procedure can be performed >30 days after index procedure Able to provide written informed consent and willing to comply with specified follow-up evaluation schedule Exclusion Criteria: Tissue loss or gangrene (Rutherford class 5 and 6) Previous bypass surgery or stenting in target vessel Untreated aortoiliac or common femoral artery inflow disease >50% Intervention of ipsilateral lesions during the index procedure or staged intervention within 30 days after index procedure

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Bryan Ping Yen Yan

Organizational Affiliation

Chinese University of Hong Kong

Official's Role

Principal Investigator

Facility Information:

Facility Name

Prince of Wales Hospital

City

Shatin

State/Province

New Territories

Country

Hong Kong

12. IPD Sharing Statement

Citations:

PubMed Identifier

10666287

Citation

Dormandy JA, Rutherford RB. Management of peripheral arterial disease (PAD). TASC Working Group. TransAtlantic Inter-Society Consensus (TASC). J Vasc Surg. 2000 Jan;31(1 Pt 2):S1-S296. No abstract available.

Results Reference

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PubMed Identifier

1294068

Citation

Johnston KW. Femoral and popliteal arteries: reanalysis of results of balloon angioplasty. Radiology. 1992 Jun;183(3):767-71. doi: 10.1148/radiology.183.3.1294068.

Results Reference

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PubMed Identifier

11094034

Citation

Minar E, Pokrajac B, Maca T, Ahmadi R, Fellner C, Mittlbock M, Seitz W, Wolfram R, Potter R. Endovascular brachytherapy for prophylaxis of restenosis after femoropopliteal angioplasty : results of a prospective randomized study. Circulation. 2000 Nov 28;102(22):2694-9. doi: 10.1161/01.cir.102.22.2694.

Results Reference

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PubMed Identifier

1825050

Citation

Capek P, McLean GK, Berkowitz HD. Femoropopliteal angioplasty. Factors influencing long-term success. Circulation. 1991 Feb;83(2 Suppl):I70-80.

Results Reference

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PubMed Identifier

8959493

Citation

Henry M, Amor M, Beyar R, Henry I, Porte JM, Mentre B, Tricoche O, Ethevenot G. Clinical experience with a new nitinol self-expanding stent in peripheral arteries. J Endovasc Surg. 1996 Nov;3(4):369-79. doi: 10.1583/1074-6218(1996)0032.0.CO;2.

Results Reference

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PubMed Identifier

11200349

Citation

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PubMed Identifier

9354709

Citation

Vroegindeweij D, Vos LD, Tielbeek AV, Buth J, vd Bosch HC. Balloon angioplasty combined with primary stenting versus balloon angioplasty alone in femoropopliteal obstructions: A comparative randomized study. Cardiovasc Intervent Radiol. 1997 Nov-Dec;20(6):420-5. doi: 10.1007/s002709900186.

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PubMed Identifier

11487673

Citation

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PubMed Identifier

10811511

Citation

Zdanowski Z, Albrechtsson U, Lundin A, Jonung T, Ribbe E, Thorne J, Norgren L. Percutaneous transluminal angioplasty with or without stenting for femoropopliteal occlusions? A randomized controlled study. Int Angiol. 1999 Dec;18(4):251-5.

Results Reference

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PubMed Identifier

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Citation

Becquemin JP, Favre JP, Marzelle J, Nemoz C, Corsin C, Leizorovicz A. Systematic versus selective stent placement after superficial femoral artery balloon angioplasty: a multicenter prospective randomized study. J Vasc Surg. 2003 Mar;37(3):487-94. doi: 10.1067/mva.2003.155.

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PubMed Identifier

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Citation

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Citation

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First-in-man Study of Titanium-Nitride Coated Woven-nitinol Peripheral Arterial Stent

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