Deep Vein ThrombosisNCT04694248
Anticoagulant Plus Antiplatelet Therapy Following Iliac Vein Stenting
A study testing Rivaroxaban and Aspirin in people with Deep Vein Thrombosis and Iliac Vein Thrombosis, run by First Affiliated Hospital of Zhejiang University at 1 site in China.
Trial summary
To evaluate the efficacy and safety of combination of anticoagulant and antiplatelet therapy on the patency of iliac vein at 12-month post stenting in patients with acute proximal DVT and ipsilateral iliac vein stenosis who received percutaneous mechanic thrombectomy and iliac vein stenting. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Deep Vein Thrombosis, Iliac Vein Thrombosis, Iliac Vein Obstruction
- What is being tested?
- Rivaroxaban and Aspirin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 172 participants
- Where
- 1 siteChina
- Study dates
- 3 Nov 2021to 30 Jun 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- IC1. Subjects who were diagnosed with deep venous thrombus (DVT) with ipsilateral iliac venous stenosis (>50%). The ipsilateral iliac venous stenosis can be caused either by iliac vein compression (i.e. Cockett syndrome) or residue iliac venous thrombus after percutaneous mechanic thrombectomy.
- IC2. Subjects who accepted percutaneous mechanic thrombectomy (PMT) to decrease the burden of thrombus, with or without catheter directed thrombolysis (CDT).
- IC3. Subjects who accepted iliac venous stent(s) implantation during the perioperative period of PMT or CDT (≤30 days post PMT or CDT) .
Who cannot join
- EC1. Subject has chronic DVT or the onset of DVT is longer than 3 weeks, or chronic DVT.
- EC2. Subject has isolated distal DVT, which does not affect ipsilateral femoral or iliac vein.
- EC3. Subject has glomerular filtration rate < 60ml/min. EC4. Subject has ipsilateral varicose vein or suffers from ipsilateral venous insufficiency prior to the DVT. The manifestations of venous insufficiency include skin pigmentation, edema, lipodermatosclerosis and venous ulcer.
- EC5. Subject has acute arterial embolism on either side or suffers from known moderate or greater stenosis at abdominal aorta, ipsilateral iliac artery and ipsilateral lower extremity artery.
- EC6. Subject has known aneurysm(s) or current limiting dissection at abdominal aorta, ipsilateral iliac artery and ipsilateral lower extremity artery.
- EC7. Subject has contraindication to antiplatelet drugs or anticoagulants. EC8. Subject has systemic disease(s) that cannot be treated by current medicine.
Show all 9Show fewer
- EC9. Subject has been taking anticoagulants or antiplatelet drugs for other diseases prior to the DVT.
- EC10. Subject less than 18 years old or rejected to join this study. EC11. Subject has myocardial infarction during the past 6 months. EC12. EC12. Subject who is at high bleeding risk.
- Subject who has at least one of the below conditions will be considered at high bleeding risk: Primary history of intracerebral haemorrhage or ischemic stroke, history of other intracranial pathology, recent gastrointestinal bleeding or anaemia due to possible gastrointestinal blood loss, other gastrointestinal pathology associated with increased bleeding risk, liver failure, bleeding diathesis or coagulopathy, extreme old age or frailty, or renal failure requiring dialysis or with eGFR <15ml/min/1.73 m2.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
The First Affliated Hospital, Zhejiang University, School of Medicine
Hangzhou, Zhejiang
Hongkun Zhang
About this study
To evaluate the efficacy and safety of combination of anticoagulant and antiplatelet therapy on the patency of iliac vein at 12-month post stenting in patients with acute proximal DVT and ipsilateral iliac vein stenosis who received percutaneous mechanic thrombectomy and iliac vein stenting.
Read the detailed description
This study is a single-arm, prospective, open-label, multicenter study conducted in the Zhejiang Province, China. Randomized controlled trial is not an optimum option at this stage given the lack of high-quality data in terms of this hypothesis. Eligible subjects will include men and women with age of 18 years or older, who have a confirmed diagnosis of acute proximal DVT with ipsilateral iliac vein stenosis. A total of 172 subjects will be enrolled. The inclusion criteria and exclusion criteria are pre-defined. Subjects meeting all inclusion and no exclusion criteria will be eligible for enrollment. All subjects will receive the combination of anticoagulant and antiplatelet therapy after implanted with iliac vein stent. For anticoagulant, it is rivaroxaban 20mg once a day for 6 months. For antiplatelet therapy, it is aspirin 100mg once a day indefinitely.The duration of study participation for each subject is 12 months. Each subject will be followed at 3 months, 6 months and 12 months post-procedure. Efficacy endpoints and safety endpoints will be documented during the follow-up. After completing the follow-up, data will be analyzed.
- Conditions
- Deep Vein Thrombosis, Iliac Vein Thrombosis, Iliac Vein Obstruction, Iliac Vein Stenosis, Iliac Vein Compression Syndrome
- Being tested
- Rivaroxaban, Aspirin
- Keywords
- acute proximal deep vein thrombosis, iliac vein stenting
- Medical subject headings
- Venous Thrombosis, May-Thurner Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RivaroxabanDrug
Also called Anticoagulant
For anticoagulant, it is rivaroxaban 20mg once a day for 6 months.
AspirinDrug
Also called Antiplatelet
For antiplatelet therapy, it is aspirin 100mg once a day indefinitely.
| Study group | Role | What they receive |
|---|---|---|
| Anticoagulant plus antiplatelet therapy | Experimental | For anticoagulant, it is rivaroxaban 20mg once a day for 6 months. For antiplatelet therapy, it is aspirin 100mg once a day indefinitely. Receives: Drug: Rivaroxaban; Drug: Aspirin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary Effectiveness Endpoints
The primary patency at 12-month follow-up evaluated by DUS
Measured: 12-month follow-up
Primary Safety Endpoints
The rate of major bleeding events (BARC type 5 or type 3) based on BARC definitions at 12-month follow-up.
Measured: 12-month follow-up
Secondary outcomes (4)
Patency
The primary patency at 3-month and 6-month follow-up
Measured: 3-month and 6-month follow-up
The rate of bleeding events
The rate of bleeding events based on BARC definitions at 3-month, 6-month and 12-month follow-up
Measured: 3-month, 6-month and 12-month follow-up
The rate and severity of post-thrombotic syndrome
The rate and severity of post-thrombotic syndrome (Villalta score) at 3-month, 6-month and 12-month follow-up
Measured: 3-month, 6-month and 12-month follow-up
The recurrence rate of deep venous thrombosis
The recurrence rate of deep venous thrombosis evaluated by DUS at 3-month, 6-month and 12-month follow-up
Measured: 3-month, 6-month and 12-month follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jan 2021
- Study start3 Nov 2021
- Primary completion31 Dec 2026 (estimated)
- Study completion30 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for Deep Vein ThrombosisStudies of the same condition, open and under way.
- More trials run by First Affiliated Hospital of Zhejiang UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 172 participants (estimated)
Sponsor and investigators
- Lead sponsor
- First Affiliated Hospital of Zhejiang University
- Sponsor type
- University, hospital or other
- Collaborators
- Ningbo No.2 Hospital, Taizhou Hospital of Zhejiang Province affiliated to Wenzhou Medical University, The Central Hospital of Lishui City, Taizhou Enze Medical Center Group, Taizhou First People's Hospital, Boston Scientific Corporation
- Responsible party
- Principal investigator, Hongkun Zhang, MD, First Affiliated Hospital of Zhejiang University
- Investigators
- Hongkun Zhang, M.D., Principal investigator, First Affiliated Hospital of Zhejiang University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04694248
- Sponsor's protocol ID
- IIT20200040C
- Status last verified
- Sep 2025
- First submitted
- 1 Jan 2021
- Last updated
- 25 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Deitelzweig SB, Johnson BH, Lin J, Schulman KL. Prevalence of clinical venous thromboembolism in the USA: current trends and future projections. Am J Hematol. 2011 Feb;86(2):217-20. doi: 10.1002/ajh.21917.
PubMed 21264912Haig Y, Enden T, Grotta O, Klow NE, Slagsvold CE, Ghanima W, Sandvik L, Hafsahl G, Holme PA, Holmen LO, Njaaastad AM, Sandbaek G, Sandset PM; CaVenT Study Group. Post-thrombotic syndrome after catheter-directed thrombolysis for deep vein thrombosis (CaVenT): 5-year follow-up results of an open-label, randomised controlled trial. Lancet Haematol. 2016 Feb;3(2):e64-71. doi: 10.1016/S2352-3026(15)00248-3. Epub 2016 Jan 6.
PubMed 26853645Garcia MJ, Lookstein R, Malhotra R, Amin A, Blitz LR, Leung DA, Simoni EJ, Soukas PA. Endovascular Management of Deep Vein Thrombosis with Rheolytic Thrombectomy: Final Report of the Prospective Multicenter PEARL (Peripheral Use of AngioJet Rheolytic Thrombectomy with a Variety of Catheter Lengths) Registry. J Vasc Interv Radiol. 2015 Jun;26(6):777-85; quiz 786. doi: 10.1016/j.jvir.2015.01.036. Epub 2015 Mar 29.
PubMed 25824314Comerota AJ, Kearon C, Gu CS, Julian JA, Goldhaber SZ, Kahn SR, Jaff MR, Razavi MK, Kindzelski AL, Bashir R, Patel P, Sharafuddin M, Sichlau MJ, Saad WE, Assi Z, Hofmann LV, Kennedy M, Vedantham S; ATTRACT Trial Investigators. Endovascular Thrombus Removal for Acute Iliofemoral Deep Vein Thrombosis. Circulation. 2019 Feb 26;139(9):1162-1173. doi: 10.1161/CIRCULATIONAHA.118.037425.
PubMed 30586751Razavi MK, Jaff MR, Miller LE. Safety and Effectiveness of Stent Placement for Iliofemoral Venous Outflow Obstruction: Systematic Review and Meta-Analysis. Circ Cardiovasc Interv. 2015 Oct;8(10):e002772. doi: 10.1161/CIRCINTERVENTIONS.115.002772.
PubMed 26438686Rizvi SA, Ascher E, Hingorani A, Marks N. Stent patency in patients with advanced chronic venous disease and nonthrombotic iliac vein lesions. J Vasc Surg Venous Lymphat Disord. 2018 Jul;6(4):457-463. doi: 10.1016/j.jvsv.2018.02.004.
PubMed 29909853Milinis K, Thapar A, Shalhoub J, Davies AH. Antithrombotic Therapy Following Venous Stenting: International Delphi Consensus. Eur J Vasc Endovasc Surg. 2018 Apr;55(4):537-544. doi: 10.1016/j.ejvs.2018.01.007. Epub 2018 Feb 12.
PubMed 29449145Gurbel PA, Fox KAA, Tantry US, Ten Cate H, Weitz JI. Combination Antiplatelet and Oral Anticoagulant Therapy in Patients With Coronary and Peripheral Artery Disease. Circulation. 2019 Apr 30;139(18):2170-2185. doi: 10.1161/CIRCULATIONAHA.118.033580.
PubMed 31034291Langwieser N, Bernlochner I, Wustrow I, Dirschinger RJ, Jaitner J, Dommasch M, Bradaric C, Laugwitz KL, Ibrahim T. Combination of factor Xa inhibition and antiplatelet therapy after stenting in patients with iliofemoral post-thrombotic venous obstruction. Phlebology. 2016 Jul;31(6):430-7. doi: 10.1177/0268355515596289. Epub 2015 Jul 15.
PubMed 26183668Endo M, Jahangiri Y, Horikawa M, Kaufman JA, Schenning RC, Kolbeck KJ, Barton RE, Ohuchi Y, Liang KW, Farsad K. Antiplatelet Therapy is Associated with Stent Patency After Iliocaval Venous Stenting. Cardiovasc Intervent Radiol. 2018 Nov;41(11):1691-1698. doi: 10.1007/s00270-018-2062-5. Epub 2018 Aug 17.
PubMed 30120531
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Anticoagulant Plus Antiplatelet Therapy Following Iliac Vein Stenting
- ClinicalTrials.gov ID
- NCT04694248
- Acronym / sponsor ID
- IIT20200040C
- Conditions
- Deep Vein Thrombosis, Iliac Vein Thrombosis, Iliac Vein Obstruction, Iliac Vein Stenosis, Iliac Vein Compression Syndrome
- Keywords
- acute proximal deep vein thrombosis, iliac vein stenting
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 172 participants (estimated)
- Lead sponsor
- First Affiliated Hospital of Zhejiang UniversityUniversity, hospital or other
- Collaborators
- Ningbo No.2 Hospital, Taizhou Hospital of Zhejiang Province affiliated to Wenzhou Medical University, The Central Hospital of Lishui City, Taizhou Enze Medical Center Group, Taizhou First People's Hospital, Boston Scientific Corporation
- Study start
- 3 Nov 2021 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 30 Jun 2027 (estimated)
- First posted
- 5 Jan 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To evaluate the efficacy and safety of combination of anticoagulant and antiplatelet therapy on the patency of iliac vein at 12-month post stenting in patients with acute proximal DVT and ipsilateral iliac vein stenosis who received percutaneous mechanic thrombectomy and iliac vein stenting.
Detailed description
This study is a single-arm, prospective, open-label, multicenter study conducted in the Zhejiang Province, China. Randomized controlled trial is not an optimum option at this stage given the lack of high-quality data in terms of this hypothesis. Eligible subjects will include men and women with age of 18 years or older, who have a confirmed diagnosis of acute proximal DVT with ipsilateral iliac vein stenosis. A total of 172 subjects will be enrolled. The inclusion criteria and exclusion criteria are pre-defined. Subjects meeting all inclusion and no exclusion criteria will be eligible for enrollment. All subjects will receive the combination of anticoagulant and antiplatelet therapy after implanted with iliac vein stent. For anticoagulant, it is rivaroxaban 20mg once a day for 6 months. For antiplatelet therapy, it is aspirin 100mg once a day indefinitely.The duration of study participation for each subject is 12 months. Each subject will be followed at 3 months, 6 months and 12 months post-procedure. Efficacy endpoints and safety endpoints will be documented during the follow-up. After completing the follow-up, data will be analyzed.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Anticoagulant plus antiplatelet therapy | Experimental | Drug: Rivaroxaban, Drug: AspirinFor anticoagulant, it is rivaroxaban 20mg once a day for 6 months. For antiplatelet therapy, it is aspirin 100mg once a day indefinitely. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- IC1. Subjects who were diagnosed with deep venous thrombus (DVT) with ipsilateral iliac venous stenosis (>50%). The ipsilateral iliac venous stenosis can be caused either by iliac vein compression (i.e. Cockett syndrome) or residue iliac venous thrombus after percutaneous mechanic thrombectomy.
- IC2. Subjects who accepted percutaneous mechanic thrombectomy (PMT) to decrease the burden of thrombus, with or without catheter directed thrombolysis (CDT).
- IC3. Subjects who accepted iliac venous stent(s) implantation during the perioperative period of PMT or CDT (≤30 days post PMT or CDT) .
Key exclusion criteria (9 listed)
- EC1. Subject has chronic DVT or the onset of DVT is longer than 3 weeks, or chronic DVT.
- EC2. Subject has isolated distal DVT, which does not affect ipsilateral femoral or iliac vein.
- EC3. Subject has glomerular filtration rate < 60ml/min. EC4. Subject has ipsilateral varicose vein or suffers from ipsilateral venous insufficiency prior to the DVT. The manifestations of venous insufficiency include skin pigmentation, edema, lipodermatosclerosis and venous ulcer.
- EC5. Subject has acute arterial embolism on either side or suffers from known moderate or greater stenosis at abdominal aorta, ipsilateral iliac artery and ipsilateral lower extremity artery.
- EC6. Subject has known aneurysm(s) or current limiting dissection at abdominal aorta, ipsilateral iliac artery and ipsilateral lower extremity artery.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RivaroxabanAlso: AnticoagulantFor anticoagulant, it is rivaroxaban 20mg once a day for 6 months. | Drug | Anticoagulant plus antiplatelet therapy |
| AspirinAlso: AntiplateletFor antiplatelet therapy, it is aspirin 100mg once a day indefinitely. | Drug | Anticoagulant plus antiplatelet therapy |
Primary outcome
Primary Effectiveness Endpoints
Time frame: 12-month follow-up
The primary patency at 12-month follow-up evaluated by DUS
Primary Safety Endpoints
Time frame: 12-month follow-up
The rate of major bleeding events (BARC type 5 or type 3) based on BARC definitions at 12-month follow-up.
4 secondary outcomes
Patency
Time frame: 3-month and 6-month follow-up
The rate of bleeding events
Time frame: 3-month, 6-month and 12-month follow-up
The rate and severity of post-thrombotic syndrome
Time frame: 3-month, 6-month and 12-month follow-up
The recurrence rate of deep venous thrombosis
Time frame: 3-month, 6-month and 12-month follow-up
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Sep 2025.
- Background: PubMed 21264912Deitelzweig SB, Johnson BH, Lin J, Schulman KL. Prevalence of clinical venous thromboembolism in the USA: current trends and future projections. Am J Hematol. 2011 Feb;86(2):217-20. doi: 10.1002/ajh.21917.
- Background: PubMed 26853645Haig Y, Enden T, Grotta O, Klow NE, Slagsvold CE, Ghanima W, Sandvik L, Hafsahl G, Holme PA, Holmen LO, Njaaastad AM, Sandbaek G, Sandset PM; CaVenT Study Group. Post-thrombotic syndrome after catheter-directed thrombolysis for deep vein thrombosis (CaVenT): 5-year follow-up results of an open-label, randomised controlled trial. Lancet Haematol. 2016 Feb;3(2):e64-71. doi: 10.1016/S2352-3026(15)00248-3. Epub 2016 Jan 6.
- Background: PubMed 25824314Garcia MJ, Lookstein R, Malhotra R, Amin A, Blitz LR, Leung DA, Simoni EJ, Soukas PA. Endovascular Management of Deep Vein Thrombosis with Rheolytic Thrombectomy: Final Report of the Prospective Multicenter PEARL (Peripheral Use of AngioJet Rheolytic Thrombectomy with a Variety of Catheter Lengths) Registry. J Vasc Interv Radiol. 2015 Jun;26(6):777-85; quiz 786. doi: 10.1016/j.jvir.2015.01.036. Epub 2015 Mar 29.
- Background: PubMed 30586751Comerota AJ, Kearon C, Gu CS, Julian JA, Goldhaber SZ, Kahn SR, Jaff MR, Razavi MK, Kindzelski AL, Bashir R, Patel P, Sharafuddin M, Sichlau MJ, Saad WE, Assi Z, Hofmann LV, Kennedy M, Vedantham S; ATTRACT Trial Investigators. Endovascular Thrombus Removal for Acute Iliofemoral Deep Vein Thrombosis. Circulation. 2019 Feb 26;139(9):1162-1173. doi: 10.1161/CIRCULATIONAHA.118.037425.
- Background: PubMed 26438686Razavi MK, Jaff MR, Miller LE. Safety and Effectiveness of Stent Placement for Iliofemoral Venous Outflow Obstruction: Systematic Review and Meta-Analysis. Circ Cardiovasc Interv. 2015 Oct;8(10):e002772. doi: 10.1161/CIRCINTERVENTIONS.115.002772.
- Background: PubMed 29909853Rizvi SA, Ascher E, Hingorani A, Marks N. Stent patency in patients with advanced chronic venous disease and nonthrombotic iliac vein lesions. J Vasc Surg Venous Lymphat Disord. 2018 Jul;6(4):457-463. doi: 10.1016/j.jvsv.2018.02.004.
- Background: PubMed 29449145Milinis K, Thapar A, Shalhoub J, Davies AH. Antithrombotic Therapy Following Venous Stenting: International Delphi Consensus. Eur J Vasc Endovasc Surg. 2018 Apr;55(4):537-544. doi: 10.1016/j.ejvs.2018.01.007. Epub 2018 Feb 12.
- Background: PubMed 31034291Gurbel PA, Fox KAA, Tantry US, Ten Cate H, Weitz JI. Combination Antiplatelet and Oral Anticoagulant Therapy in Patients With Coronary and Peripheral Artery Disease. Circulation. 2019 Apr 30;139(18):2170-2185. doi: 10.1161/CIRCULATIONAHA.118.033580.
- Background: PubMed 26183668Langwieser N, Bernlochner I, Wustrow I, Dirschinger RJ, Jaitner J, Dommasch M, Bradaric C, Laugwitz KL, Ibrahim T. Combination of factor Xa inhibition and antiplatelet therapy after stenting in patients with iliofemoral post-thrombotic venous obstruction. Phlebology. 2016 Jul;31(6):430-7. doi: 10.1177/0268355515596289. Epub 2015 Jul 15.
- Background: PubMed 30120531Endo M, Jahangiri Y, Horikawa M, Kaufman JA, Schenning RC, Kolbeck KJ, Barton RE, Ohuchi Y, Liang KW, Farsad K. Antiplatelet Therapy is Associated with Stent Patency After Iliocaval Venous Stenting. Cardiovasc Intervent Radiol. 2018 Nov;41(11):1691-1698. doi: 10.1007/s00270-018-2062-5. Epub 2018 Aug 17.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Hongkun Zhang, M.D. principal investigator
First Affiliated Hospital of Zhejiang University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Rivaroxaban and Aspirin in people with Deep Vein Thrombosis and Iliac Vein Thrombosis, run by First Affiliated Hospital of Zhejiang University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 25 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Hongkun Zhang, M.D. (0571-87236745, 1198050@zju.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Primary Effectiveness Endpoints (time frame: 12-month follow-up). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04694248, which also lists 10 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Sep 2025; AzTrials last refreshed its copy on 8 Nov 2026.