NCT05324787

Completed

Treatment of Vein Stenosis or Occlusion With the Oblique Ste...

Hangzhou Endonom Medtech Co., Ltd.Source

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Other study identifiers

Sponsor study identifier

GR001

Study Type

interventional

Actual enrollment (reported)

112

Locations

1 country

Sites

2

Timeline

Study Start

August 22, 2019

Actual (reported)

Primary Completion

December 9, 2021

Actual (reported)

Study Completion

December 9, 2021

Actual (reported)

Brief Summary

To evaluate the safety and effectiveness of Grency venous stent system in the treatment of iliac vein stenosis or occlusion.

Registry Overview

Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.

Recruitment status: completed
Actual enrollment (reported): 112 participants
Study completion date: December 9, 2021
Actual (reported)
Listed locations: 1 countries · 2 sites

Trial Relationships

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Some registry-reported names shown below are not yet linked in this graph.

Study Timeline

Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.

Study Start
August 22, 2019
Actual (reported)
Primary Completion
December 9, 2021
Actual (reported)
Study Completion
December 9, 2021
Actual (reported)
First Submitted
March 31, 2022
Actual (reported)
First Posted
April 12, 2022
Actual (reported)

Last Updated: April 12, 2022
Status Verified: April 2022
Last Update Submitted: April 10, 2022

Conditions

Iliac Vein Occlusion Iliac Vein Stenosis

Outcome Measures

Primary Outcomes (1)

Patency rate of venous stent
Freedom from target vessel revascularization ; freedom from in-stent stenosis more than 50% by venography.
12 months post-intervention

Secondary Outcomes (4)

The rate of procedural technical success
During procedure
Change in the clinical symptoms
Baseline, 3 months,6 months, and12 months post-intervention
The rate of device related major adverse events(MAE)
3,6,12 months post-intervention
The rate of adverse events (AE)
3,6,12 months post-intervention

Study Arms (1)

Grency venous stent system

EXPERIMENTAL

Device: Grency venous stent system

Interventions

Grency venous stent systemDevice

Venous stent implantation during the index procedure

Grency venous stent system

Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.

Eligibility Criteria

Age18 Years - 80 Years

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

subjects aged 18-80 years;
CEAP clinical grade C \>=3;

Sponsors & Collaborators

Hangzhou Endonom Medtech Co., Ltd.
Industrylead

Study Sites (2)

Chinese People's Liberation Army General Hospital

Beijing, China

Zhongshan Hospital Affiliated to Fudan University

Shanghai, China

Enrollment

112 participants (actual enrollment reported by the registry).

Study Design

Study Type: interventional
Phase: not applicable
Allocation: NA
Masking: NONE
Purpose: TREATMENT
Intervention Model: SINGLE GROUP
Sponsor Type: INDUSTRY
Responsible Party: SPONSOR

Study Record Dates

First Submitted

March 31, 2022

First Posted

April 12, 2022

Study Start

August 22, 2019

Actual (reported)

iliac vein stenosis \>=50% or occlusion;

patients voluntarily sign informed consent and complete follow-up.

You may not qualify if:

subjects in pregnancy or lactation;
renal insufficiency;
subjects are allergic to contrast agents and anesthetics;
subjects are allergic to nitinol;
the life expectancy of cancer patients is less than 1 year;
the length of the stent is expected to exceed the length of the inguinal ligament; 7. both sides of iliac vein stents were required;
\. long term bedridden or wheelchair patients; 9. the target vessel of the subject has been implanted into the iliac vein stent; 10. subjects have anticoagulant contraindications or are unable to receive long-term new oral anticoagulant therapy; 11. the investigator judged that the subjects had poor compliance and could not complete the clinical trial; 12. subjects are participating in clinical trials of other drugs or medical devices and have not yet completed the primary end point of the study.

Contact the study team to confirm eligibility.

Primary Completion

December 9, 2021

Actual (reported)

Study Completion

December 9, 2021

Actual (reported)

Last Updated

April 12, 2022

Record last verified: 2022-04

Data Sharing

IPD Sharing: Will not share

Source record

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Source: ClinicalTrials.gov.

JSON downloads include source attribution and retrieval details alongside the unchanged original record or the separately normalized values.

Registry identifier: NCT05324787
Data provider: ClinicalTrials.gov
Source updated: 2022-04-12
Normalization version: ctgov-legacy-1

Open registry record

Source retrieved: 2026-10-25 22:22:52 UTC

Locations

CN(2)

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

Primary Completion

Study Completion

First Submitted

First Posted

Conditions

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (4)

Study Arms (1)

Grency venous stent system

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (2)

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source record

Locations