Evidence map›Paper›PMID 35842583›Full record

ArticleBMC cardiovascular disorders2022

Excimer laser ablation combined with drug-coated balloon versus drug-coated balloon in the treatment of de novo atherosclerotic lesions in lower extremities (ELABORATE): study protocol for a real-world clinical trial.

Xiaolang Jiang, Longhua Fan, Bin Chen, Junhao Jiang, Jianjun Liu, Guanyu Qiao, Shuai Ju, Yun Shi, Tao Ma, Changpo Lin and 5 more

Open access · goldAbstract readClinical Trial Protocol
PubMed Full text at PMC Publisher
In one paragraph

Article in BMC cardiovascular disorders, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.

0numbers the graph read from it
0cells of the map it votes in
0citing papers in PubMed
0.7field-weighted citation impact, top 31% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

0 citing papers in PubMed, 3 citations in OpenAlex.

No citing paper in PubMed yet.

4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

15 authors at 2 institutions in 1 country.

Xiaolang Jiang *Department of Vascular Surgery, Institute of Vascular Surgery, Zhongshan Hospital, Fudan University, National Clinical Research Center for Interventional Medicine, 180 Fenglin Road, Shanghai, 200032, China.
Longhua Fan *Department of Vascular Surgery, Qingpu Branch of Zhongshan Hospital, Fudan University, 1158 East Gongyuan Road, Shanghai, 201715, China.
Bin ChenDepartment of Vascular Surgery, Institute of Vascular Surgery, Zhongshan Hospital, Fudan University, National Clinical Research Center for Interventional Medicine, 180 Fenglin Road, Shanghai, 200032, China.
Junhao JiangDepartment of Vascular Surgery, Institute of Vascular Surgery, Zhongshan Hospital, Fudan University, National Clinical Research Center for Interventional Medicine, 180 Fenglin Road, Shanghai, 200032, China.
Jianjun LiuDepartment of Vascular Surgery, Qingpu Branch of Zhongshan Hospital, Fudan University, 1158 East Gongyuan Road, Shanghai, 201715, China.
Guanyu QiaoDepartment of Vascular Surgery, Institute of Vascular Surgery, Zhongshan Hospital, Fudan University, National Clinical Research Center for Interventional Medicine, 180 Fenglin Road, Shanghai, 200032, China.
Shuai JuDepartment of Vascular and Wound Treatment Center, Jinshan Hospital, Fudan University, Shanghai, 200540, China.
Yun ShiDepartment of Vascular Surgery, Institute of Vascular Surgery, Zhongshan Hospital, Fudan University, National Clinical Research Center for Interventional Medicine, 180 Fenglin Road, Shanghai, 200032, China.
Tao MaDepartment of Vascular Surgery, Institute of Vascular Surgery, Zhongshan Hospital, Fudan University, National Clinical Research Center for Interventional Medicine, 180 Fenglin Road, Shanghai, 200032, China.
Changpo LinDepartment of Vascular Surgery, Institute of Vascular Surgery, Zhongshan Hospital, Fudan University, National Clinical Research Center for Interventional Medicine, 180 Fenglin Road, Shanghai, 200032, China.
Gang FangDepartment of Vascular Surgery, Institute of Vascular Surgery, Zhongshan Hospital, Fudan University, National Clinical Research Center for Interventional Medicine, 180 Fenglin Road, Shanghai, 200032, China.
Daqiao GuoDepartment of Vascular Surgery, Institute of Vascular Surgery, Zhongshan Hospital, Fudan University, National Clinical Research Center for Interventional Medicine, 180 Fenglin Road, Shanghai, 200032, China.
Xin XuDepartment of Vascular Surgery, Institute of Vascular Surgery, Zhongshan Hospital, Fudan University, National Clinical Research Center for Interventional Medicine, 180 Fenglin Road, Shanghai, 200032, China.
Zhihui DongDepartment of Vascular Surgery, Institute of Vascular Surgery, Zhongshan Hospital, Fudan University, National Clinical Research Center for Interventional Medicine, 180 Fenglin Road, Shanghai, 200032, China. dzh926@126.com.ORCID 0000-0002-3754-2458
Weiguo FuDepartment of Vascular Surgery, Institute of Vascular Surgery, Zhongshan Hospital, Fudan University, National Clinical Research Center for Interventional Medicine, 180 Fenglin Road, Shanghai, 200032, China.
Fudan University · CNJinshan Hospital of Fudan University · CN

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundThe efficacy and validity of excimer laser ablation (ELA) in the in-stent restenosis (ISR) has been confirmed. However, its application in de novo atherosclerotic lesions of lower extremity artery disease (LEAD) has not been clearly defined and its procedure has not been standardized.

methodsELABORATE is a prospective, multicenter, real-world study designed to evaluate the efficacy and safety between ELA combined with drug-coated balloon (DCB) and DCB alone in de novo atherosclerotic lesions of LEAD. DISCUSSION: ELABORATE is a prospective, multicenter, real-world study designed to assess the efficacy and safety between ELA combined with drug-coated balloon (DCB) and DCB alone in patients with de novo atherosclerotic lesions of LEAD. According to the real-world situation, eligible patients will be allocated to ELA + DCB group (group E) and DCB group (group C). Baseline and follow-up information (at 3, 6, and 12 months) will be collected. The primary efficacy point is primary patency at 12-months, and the secondary efficacy points include clinically driven target lesion reintervention (CD-TLR), change of Rutherford class, ankle-brachial index and ulcer healing rate. These indexes will be assessed and recorded at 3, 6, and 12-month follow-up. Also, safety evaluation, including major adverse event, all-cause mortality through 30-day follow-up, unplanned major amputation, bailout stent and distal embolization, will also be evaluated by an independent core laboratory. All the data will be collected and recorded by the electric data capture system. This study will be finished in 3 years and the 12-month results will be available in 2023. All the patients will be followed for 5 years. Trial registration number Chinese Clinical Trial Registry (ChiCTR2100051263). Registered 17 September 2019. http://www.chictr.org.cn/listbycreater.aspx .

Indexed as

Angioplasty, BalloonLaser TherapyPeripheral Arterial DiseaseCombined Modality TherapyConstriction, PathologicHumansLower ExtremityMulticenter Studies as TopicProspective StudiesTreatment OutcomeVascular PatencyAtherosclerotic obliteransDe novo lesionsDrug-coated balloonExcimer laser ablation

Identifiers

PMID35842583
PMCPMC9287897
OpenAlexW4285588446

What OpenQuestion holds

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Registered trials

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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.