May-Thurner SyndromePhase 3PLICTSNCT04067505
Rivaroxaban for the Prevention of Deep Vein Thrombosis in Patients With Left Iliac Vein Compression - The PLICTS Study
A Phase 3 study testing Rivaroxaban, Warfarin and Nadroparin in people with May-Thurner Syndrome, run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 9 sites in China.
Trial summary
The purpose of this study is to evaluate the efficacy and safety of rivaroxaban for the prevention of deep vein thrombosis in patients with left iliac vein compression treated with stent implantation. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- May-Thurner Syndrome
- What is being tested?
- Rivaroxaban, Warfarin and Nadroparin
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 224 participants
- Where
- 9 sitesChina
- Study dates
- 18 May 2020to 31 Dec 2024
- Phase
- Phase 3
- Are there results?
- None posted in the registry
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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with thrombotic left iliac vein compression syndrome who underwent left iliac vein stent implantation
Who cannot join
- Age < 18 years or age > 75 years
- With history of pelvic surgery, left iliac vein trauma and pelvic radiotherapy
- With obvious contraindications for anticoagulation therapy
- Allergic to iodine contrast agents in the past
- With concomitant diseases that need high-intensity anticoagulation, and the anticoagulation intensity is clearly higher than that of the patients with iliac vein therapy alone
- Active bleeding or potential bleeding risk
Show all 11Show fewer
- Pregnant or breastfeeding women
- With pelvic tumors causing compression of left iliac vein,
- With chronic venous insufficiency of lower extremities caused by K-T syndrome
- With malignant tumors and life expectancy < 1 year
- Taking cytochrome P450 3A4(CYP-450 3A4) inhibitors or inducers
Trial locations and contacts
9 sites in 1 country.
9 sites in 1 country
China9 sites, 9 recruiting
- Recruiting
Sir Run Run Shaw Hospital
Hangzhou, Zhejiang, 310000
Yuefeng Zhu, MD, 13868101010 ext. 86, drzyf@hotmail.com
- Recruiting
The second affiliated hospital of zhejiang university school of medicine
Hangzhou, Zhejiang, 310000
Zhejie Liu, MD,PhD, 15268135830 ext. 86, lawson3001@gmail.com
- Recruiting
Zhejiang Provincial people's hospital
Hangzhou, Zhejiang
Guangwei Yang, 13758146564, ygw_zju@126.com
- Recruiting
Zhejiang Xiaoshan Hospital
Hangzhou, Zhejiang
Wei Han, 18957113906, hw9453@sina.com
- Recruiting
Anhui Provincial Hospital
Hefei, Anhui, 230000
Zhengdong Fang, 15256990126 ext. 86, fangzhengdong@126.com
- Recruiting
Huadong Hospital affiliated to Fudan University
Shanghai, Shanghai Municipality, 200000
Wan Zhang, MD,PhD, 13916056910 ext. 86, ant0930@163.com
- Recruiting
Shanghai 5th People's Hospital
Shanghai, Shanghai Municipality, 200000
Bin Gao, MD,PhD, 13764979078 ext. 86, doctorgaobin@163.com
- Recruiting
Zhongshan Hospital affiliated to Fudan University
Shanghai, Shanghai Municipality, 200000
Jianing Yue, MD,PhD, 13564788422 ext. 86, yuejianing@gmail.com
- Recruiting
Yantai Yuhuangding Hospital
Yantai, Shangdong, 264000
Lubin Li, MD, 18653587255 ext. 86, 278468192@qq.com
About this study
Official title: An Efficacy and Safety Study of Rivaroxaban for the Prevention of Deep Vein Thrombosis in Patients With Left Iliac Vein Compression Treated With Stent Implantation (PLICTS)：A Prospective Randomized Controlled Trial
The purpose of this study is to evaluate the efficacy and safety of rivaroxaban for the prevention of deep vein thrombosis in patients with left iliac vein compression treated with stent implantation.
Read the detailed description
Left Iliac Vein Compression Syndrome (LIVCS) is a disease of iliac vein stenosis/occlusion caused by chronic friction and compression of the left iliac vein by the right common iliac artery and lumbar vertebra. It is also called Cockett syndrome or May-Thurner syndrome. Recently, left iliac vein balloon dilatation with stent implantation have been used to treat patients with LIVCS, and have achieved good results. However, no matter the iliac vein stenosis or occlusion, interventional therapy can directly cause local trauma and intimal injury, which is a clear inducement of local thrombosis. Therefore, high intensity anticoagulation therapy is still needed to prevent secondary thrombosis in stent after left iliac vein balloon dilatation with stent implantation. At present, the postoperative anticoagulation regimen of these patients is early heparin anticoagulant therapy, and later warfarin anticoagulant therapy. However, due to the narrow therapeutic window of the drug, patients need to adjust the dosage according to coagulation function under the guidance of doctors. Rivaroxaban can simplify treatment, and is safe. Previous studies have shown that rivaroxaban is effective in preventing deep venous thrombosis after orthopaedic surgery. Rivaroxaban has also been shown to be safe and effective in anticoagulation therapy for patients with deep venous thrombosis and pulmonary embolism. However, Rivaroxaban lacks sufficient clinical data for adjuvant anticoagulation therapy after balloon dilatation with stent implantation. Therefore, this study should be carried out to provide the basis for LIVCS treatment guidelines and explore the clinical indications of rivaroxaban.
- Conditions
- May-Thurner Syndrome
- Being tested
- Rivaroxaban, Warfarin, Nadroparin
- Keywords
- May-Thurner Syndrome, warfarin, rivaroxaban, stent implantation
- Medical subject headings
- 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 Xarelto
Dose: 15mg twice daily for three weeks, then 20mg once daily until six months after the operation. Application: oral
WarfarinDrug
Also called coumadin
Dose: 3mg for 5 days after the operation, later 0.75mg to 18mg depending on INR (2.0-3.0) until 6 months Duration: 6 months Frequency: once daily Application: oral
NadroparinDrug
Also called Fraxiparin
Dose: 1mg/kg Duration: 5 days after the operation Frequency: twice daily Application: subcutaneous
| Study group | Role | What they receive |
|---|---|---|
| Rivaroxaban | Experimental | Participants will receive rivaroxaban 15mg twice daily for three weeks, then 20mg oral once daily after operation. Receives: Drug: Rivaroxaban |
| Warfarin/Nadroparin | Active comparator | Participants will receive nadroparin 1mg/kg twice daily (subcutaneous), plus warfarin 3mg oral once daily for 5 days after the operation, later warfarin(oral) at individually titrated doses(0.75mg to 18mg) to achieve a target international normalized ratio (INR) of 2.0 to 3.0, once daily until 6 months. Receives: Drug: Warfarin; Drug: Nadroparin |
What is being measured
The primary outcome is the main question the study is designed to answer.
stent occlusion rate
Stent occlusion is defined as DS > 50% for each modality with no procedure performed on the treated segment
Measured: 2 year after operation
Secondary outcomes (7)
Quality of Life Change Scale Survey Results
Quality of life will be assessed by MOS item short-form health survey scale (SF-36). SF-36 includes eight subscales: physical functioning (PF, 10 items), role limitations due to physical health problems (RL-P, 4 items), bodily pain (BP, 2 items), general health (GH, 5 items), vitality (V, 4 items), social functioning (SF, 2 items), role limitations due to emotional problems (RL-E, 3 items) and mental health (MH, 5 items). The vitality sub-score assesses energy and fatigue, and ranges from 0 (worst) - 100 (best).
Measured: 1, 3, 6, 12, 18 and 24 months after operation
All cause mortality
Percentage of participants with all deaths
Measured: 1, 3, 6, 12, 18 and 24 months after operation
anticoagulation raleted mortality
Percentage of participants with anticoagulation raleted deaths
Measured: 1, 3, 6, 12, 18 and 24 months after operation
Proportion of participants with stent displacement/fracture
Events will be assessed based on computed tomography (CT) or X ray
Measured: 1, 3, 6, 12, 18 and 24 months after operation
Proportion of participants with hemorrhage
Including hemorrhagic stroke, gastrointestinal bleeding, hematuria, mucocutaneous hemorrhage and other visceral bleeding
Measured: 1, 3, 6, 12, 18 and 24 months after operation
Proportion of participants with other vascular events
All vascular events (ST segment elevation myocardial infarction, non ST segment elevation myocardial infarction, acute coronary syndrome, unstable angina, ischemic stroke, transient ischemic attack, pulmonary embolism, non-central nervous system systemic embolism or vascular death) will be assessed based results/films/images of confirmatory testing, and/or case summaries.
Measured: 1, 3, 6, 12, 18 and 24 months after operation
Proportion of participants with thrombosis
Measured: 1, 3, 6, 12, 18 and 24 months after operation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Aug 2019
- Study start18 May 2020
- Primary completion31 Dec 2024 (estimated)
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for May-Thurner SyndromeStudies of the same condition, open and under way.
- More trials run by Second Affiliated Hospital, Zhejiang University, School of MedicineThe 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 224 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Sir Run Run Shaw Hospital, Huadong Hospital, Shanghai Zhongshan Hospital, Shanghai 5th People's Hospital, Yantai Yuhuangding Hospital, Anhui Provincial Hospital, Zhejiang Provincial People's Hospital, Zhejiang Hospital
- Responsible party
- Principal investigator, Zhenjie Liu, Second Affiliated Hospital, Zhejiang University, School of Medicine
- Investigators
- Zhejie Liu, MD,PhD, Principal investigator, Second Affiliated Hospital, Zhejiang University, School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04067505
- Sponsor's protocol ID
- SAHZhejiangU-001
- Acronym
- PLICTS
- Status last verified
- Apr 2024
- First submitted
- 24 Jul 2019
- Last updated
- 18 Apr 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Liu Z, Gao N, Shen L, Yang J, Zhu Y, Li Z, Si Y. Endovascular treatment for symptomatic iliac vein compression syndrome: a prospective consecutive series of 48 patients. Ann Vasc Surg. 2014 Apr;28(3):695-704. doi: 10.1016/j.avsg.2013.05.019. Epub 2013 Oct 27.
PubMed 24559785O'Sullivan GJ, Semba CP, Bittner CA, Kee ST, Razavi MK, Sze DY, Dake MD. Endovascular management of iliac vein compression (May-Thurner) syndrome. J Vasc Interv Radiol. 2000 Jul-Aug;11(7):823-36. doi: 10.1016/s1051-0443(07)61796-5.
PubMed 10928517Hurst DR, Forauer AR, Bloom JR, Greenfield LJ, Wakefield TW, Williams DM. Diagnosis and endovascular treatment of iliocaval compression syndrome. J Vasc Surg. 2001 Jul;34(1):106-13. doi: 10.1067/mva.2001.114213.
PubMed 11436082Eriksson BI, Kakkar AK, Turpie AG, Gent M, Bandel TJ, Homering M, Misselwitz F, Lassen MR. Oral rivaroxaban for the prevention of symptomatic venous thromboembolism after elective hip and knee replacement. J Bone Joint Surg Br. 2009 May;91(5):636-44. doi: 10.1302/0301-620X.91B5.21691.
PubMed 19407299Turpie AG, Lassen MR, Davidson BL, Bauer KA, Gent M, Kwong LM, Cushner FD, Lotke PA, Berkowitz SD, Bandel TJ, Benson A, Misselwitz F, Fisher WD; RECORD4 Investigators. Rivaroxaban versus enoxaparin for thromboprophylaxis after total knee arthroplasty (RECORD4): a randomised trial. Lancet. 2009 May 16;373(9676):1673-80. doi: 10.1016/S0140-6736(09)60734-0. Epub 2009 May 4.
PubMed 19411100Li M, Zhang L, Zhang K, Zhu Y, Shi Z, Zhang W, Gao B, Li L, Fang Z, Yin L, Chen B, Liu Z. An efficacy and safety study of rivaroxaban for the prevention of deep vein thrombosis in patients with left iliac vein compression treated with stent implantation (PLICTS): study protocol for a prospective randomized controlled trial. Trials. 2020 Sep 29;21(1):811. doi: 10.1186/s13063-020-04742-z.
PubMed 32993773
Study at a glance
From the registry record, last updated by the sponsor on 18 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Efficacy and Safety Study of Rivaroxaban for the Prevention of Deep Vein Thrombosis in Patients With Left Iliac Vein Compression Treated With Stent Implantation (PLICTS)：A Prospective Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04067505
- Acronym / sponsor ID
- PLICTS / SAHZhejiangU-001
- Conditions
- May-Thurner Syndrome
- Keywords
- May-Thurner Syndrome, warfarin, rivaroxaban, stent implantation
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 224 participants (estimated)
- Lead sponsor
- Second Affiliated Hospital, Zhejiang University, School of MedicineUniversity, hospital or other
- Collaborators
- Sir Run Run Shaw Hospital, Huadong Hospital, Shanghai Zhongshan Hospital, Shanghai 5th People's Hospital, Yantai Yuhuangding Hospital, Anhui Provincial Hospital, Zhejiang Provincial People's Hospital, Zhejiang Hospital
- Study start
- 18 May 2020 (actual)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 26 Aug 2019 (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.
The purpose of this study is to evaluate the efficacy and safety of rivaroxaban for the prevention of deep vein thrombosis in patients with left iliac vein compression treated with stent implantation.
Detailed description
Left Iliac Vein Compression Syndrome (LIVCS) is a disease of iliac vein stenosis/occlusion caused by chronic friction and compression of the left iliac vein by the right common iliac artery and lumbar vertebra. It is also called Cockett syndrome or May-Thurner syndrome. Recently, left iliac vein balloon dilatation with stent implantation have been used to treat patients with LIVCS, and have achieved good results. However, no matter the iliac vein stenosis or occlusion, interventional therapy can directly cause local trauma and intimal injury, which is a clear inducement of local thrombosis. Therefore, high intensity anticoagulation therapy is still needed to prevent secondary thrombosis in stent after left iliac vein balloon dilatation with stent implantation. At present, the postoperative anticoagulation regimen of these patients is early heparin anticoagulant therapy, and later warfarin anticoagulant therapy. However, due to the narrow therapeutic window of the drug, patients need to adjust the dosage according to coagulation function under the guidance of doctors. Rivaroxaban can simplify treatment, and is safe. Previous studies have shown that rivaroxaban is effective in preventing deep venous thrombosis after orthopaedic surgery. Rivaroxaban has also been shown to be safe and effective in anticoagulation therapy for patients with deep venous thrombosis and pulmonary embolism. However, Rivaroxaban lacks sufficient clinical data for adjuvant anticoagulation therapy after balloon dilatation with stent implantation. Therefore, this study should be carried out to provide the basis for LIVCS treatment guidelines and explore the clinical indications of rivaroxaban.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Rivaroxaban | Experimental | Drug: RivaroxabanParticipants will receive rivaroxaban 15mg twice daily for three weeks, then 20mg oral once daily after operation. |
| Warfarin/Nadroparin | Active comparator | Drug: Warfarin, Drug: NadroparinParticipants will receive nadroparin 1mg/kg twice daily (subcutaneous), plus warfarin 3mg oral once daily for 5 days after the operation, later warfarin(oral) at individually titrated doses(0.75mg to 18mg) to achieve a target international normalized ratio (INR) of 2.0 to 3.0, once daily until 6 months. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients with thrombotic left iliac vein compression syndrome who underwent left iliac vein stent implantation
Key exclusion criteria (11 listed)
- Age < 18 years or age > 75 years
- With history of pelvic surgery, left iliac vein trauma and pelvic radiotherapy
- With obvious contraindications for anticoagulation therapy
- Allergic to iodine contrast agents in the past
- With concomitant diseases that need high-intensity anticoagulation, and the anticoagulation intensity is clearly higher than that of the patients with iliac vein therapy alone
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: XareltoDose: 15mg twice daily for three weeks, then 20mg once daily until six months after the operation. Application: oral | Drug | Rivaroxaban |
| WarfarinAlso: coumadinDose: 3mg for 5 days after the operation, later 0.75mg to 18mg depending on INR (2.0-3.0) until 6 months Duration: 6 months Frequency: once daily Application: oral | Drug | Warfarin/Nadroparin |
| NadroparinAlso: FraxiparinDose: 1mg/kg Duration: 5 days after the operation Frequency: twice daily Application: subcutaneous | Drug | Warfarin/Nadroparin |
Primary outcome
stent occlusion rate
Time frame: 2 year after operation
Stent occlusion is defined as DS > 50% for each modality with no procedure performed on the treated segment
7 secondary outcomes
Quality of Life Change Scale Survey Results
Time frame: 1, 3, 6, 12, 18 and 24 months after operation
All cause mortality
Time frame: 1, 3, 6, 12, 18 and 24 months after operation
anticoagulation raleted mortality
Time frame: 1, 3, 6, 12, 18 and 24 months after operation
Proportion of participants with stent displacement/fracture
Time frame: 1, 3, 6, 12, 18 and 24 months after operation
Proportion of participants with hemorrhage
Time frame: 1, 3, 6, 12, 18 and 24 months after operation
Proportion of participants with other vascular events
Time frame: 1, 3, 6, 12, 18 and 24 months after operation
Proportion of participants with thrombosis
Time frame: 1, 3, 6, 12, 18 and 24 months after operation
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Apr 2024.
- Background: PubMed 24559785Liu Z, Gao N, Shen L, Yang J, Zhu Y, Li Z, Si Y. Endovascular treatment for symptomatic iliac vein compression syndrome: a prospective consecutive series of 48 patients. Ann Vasc Surg. 2014 Apr;28(3):695-704. doi: 10.1016/j.avsg.2013.05.019. Epub 2013 Oct 27.
- Background: PubMed 10928517O'Sullivan GJ, Semba CP, Bittner CA, Kee ST, Razavi MK, Sze DY, Dake MD. Endovascular management of iliac vein compression (May-Thurner) syndrome. J Vasc Interv Radiol. 2000 Jul-Aug;11(7):823-36. doi: 10.1016/s1051-0443(07)61796-5.
- Background: PubMed 11436082Hurst DR, Forauer AR, Bloom JR, Greenfield LJ, Wakefield TW, Williams DM. Diagnosis and endovascular treatment of iliocaval compression syndrome. J Vasc Surg. 2001 Jul;34(1):106-13. doi: 10.1067/mva.2001.114213.
- Background: PubMed 19407299Eriksson BI, Kakkar AK, Turpie AG, Gent M, Bandel TJ, Homering M, Misselwitz F, Lassen MR. Oral rivaroxaban for the prevention of symptomatic venous thromboembolism after elective hip and knee replacement. J Bone Joint Surg Br. 2009 May;91(5):636-44. doi: 10.1302/0301-620X.91B5.21691.
- Background: PubMed 19411100Turpie AG, Lassen MR, Davidson BL, Bauer KA, Gent M, Kwong LM, Cushner FD, Lotke PA, Berkowitz SD, Bandel TJ, Benson A, Misselwitz F, Fisher WD; RECORD4 Investigators. Rivaroxaban versus enoxaparin for thromboprophylaxis after total knee arthroplasty (RECORD4): a randomised trial. Lancet. 2009 May 16;373(9676):1673-80. doi: 10.1016/S0140-6736(09)60734-0. Epub 2009 May 4.
- Derived from this study: PubMed 32993773Li M, Zhang L, Zhang K, Zhu Y, Shi Z, Zhang W, Gao B, Li L, Fang Z, Yin L, Chen B, Liu Z. An efficacy and safety study of rivaroxaban for the prevention of deep vein thrombosis in patients with left iliac vein compression treated with stent implantation (PLICTS): study protocol for a prospective randomized controlled trial. Trials. 2020 Sep 29;21(1):811. doi: 10.1186/s13063-020-04742-z.
Related trials for May-Thurner Syndrome
Recruiting
Pelvic Vein Quantitative Flow Characterization Using 2D and 4D Flow MRI
May-Thurner Syndrome, Iliac Venous Compression
Not yet recruiting
Embolization of Ovarian Vein and Pelvic Venous Reservoir for Treatment of Secondary Pelvic Congestion Syndrome
Pelvic Congestion Syndrome
RecruitingObservational study
Vascular Lab Resource (VLR) Biorepository
Cardiovascular Diseases, Metabolic Disease
Recruiting
Anticoagulant Plus Antiplatelet Therapy Following Iliac Vein Stenting
Deep Vein Thrombosis, Iliac Vein Thrombosis
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. This study is not recruiting at the moment.
Zhejie Liu, MD,PhD principal investigator
Second Affiliated Hospital, Zhejiang University, School of Medicine
9 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Rivaroxaban, Warfarin and Nadroparin in people with May-Thurner Syndrome, run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 9 sites 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 1 inclusion and 11 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: status not confirmed, as of the sponsor's last update on 18 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Li Yin (86-0571-87913706, lawson4001@zju.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
stent occlusion rate (time frame: 2 year after operation). 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 NCT04067505, which also lists 6 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 18 Apr 2024.