Evidence map›Paper›PMID 33948700›Full record

ArticleCardiovascular and interventional radiology2021

"Ranger BTK" a Prospective Single-Centre Cohort Study on a New Drug-Coated Balloon for Below the Knee Lesions in Patients with Critical Limb Ischemia.

Costantino Del Giudice, Alexandre Galloula, Clarisse Tiercelin, Aurélie Vilfaillot, Jean Marc Alsac, Emmanuel Messas, Carole L Déan, Etienne Larger, Marc Sapoval

Registry-linked trialAbstract read
PubMed Publisher
In one paragraph

Article in Cardiovascular and interventional radiology, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT07014475 (Efficacy of the Ranger Drug-Coated Balloon in Treating Below-the-Knee Lesions in Patients With Chronic Limb-Threatening Ischemia), which is not on this map. Cited by 2 papers.

0numbers the graph read from it
0cells of the map it votes in
2citing papers in PubMed
1.0field-weighted citation impact, top 24% 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.

NCT07014475 not yet recruitingnot on this mapstarted 2025, after this paper: background citation

Efficacy of the Ranger Drug-Coated Balloon in Treating Below-the-Knee Lesions in Patients With Chronic Limb-Threatening Ischemia

Typeobservational_patient_registrySponsorFirst Affiliated Hospital, Sun Yat-Sen UniversityRan2025 to 2029Enrolled700ConditionsChronic Limb Threatening IschemiaArmsdrug-coated balloon
3 · Its place in the literature

Who cites it

2 citing papers in PubMed, 6 citations in OpenAlex.

  1. Article
  2. Review
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

9 authors at 4 institutions in 1 country.

Costantino Del GiudiceDepartment of Radiology, Interventional Radiology, Institut Mutualiste Montsouris, 42 Boulevard Jourdan, 75014, Paris, France. costantino.delgiudice@imm.fr.ORCID http://orcid.org/0000-0002-9383-122X
Alexandre GalloulaDepartment of Vascular Medicine, Hôpital Européen George Pompidou, Assistance Publique Hôpitaux de Paris, 75015, Paris, France.
Clarisse TiercelinDiabetology, Hôpital Cochin, Assistance Publique Hôpitaux de Paris, 75015, Paris, France.
Aurélie VilfaillotClinical Investigation Unit, Hôpital Européen George Pompidou, Assistance Publique Hôpitaux de Paris, 75015, Paris, France.
Jean Marc AlsacVascular Surgery, Hôpital Européen George Pompidou, Assistance Publique Hôpitaux de Paris, 75015, Paris, France.
Emmanuel MessasDepartment of Vascular Medicine, Hôpital Européen George Pompidou, Assistance Publique Hôpitaux de Paris, 75015, Paris, France.
Carole L DéanVascular and Oncological Interventional Radiology, Hôpital Européen George Pompidou, Assistance Publique Hôpitaux de Paris, 75015, Paris, France.
Etienne LargerDiabetology, Hôpital Cochin, Assistance Publique Hôpitaux de Paris, 75015, Paris, France.
Marc SapovalUniversité de Paris, INSERM U970, 75015, Paris, France.
Assistance Publique – Hôpitaux de Paris · FRInserm · FRHôpital Cochin · FRInstitute Mutualiste Montsouris · FR

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

purposeRestenosis remains a limitation of endovascular angioplasty with a patency of 30% in BTK at 12 months. Several studies on drug-coated balloons have not demonstrated any improvements in terms of patency and target lesions revascularization in BTK lesions. This prospective single-centre cohort study evaluates the safety and efficacy of a new generation low-dose drug-coated balloon (DCB) with a reduced crystalline structure to treat below the knee (BTK) lesions in patients with critical limb ischemia (CLI). MATERIALS AND

methodsBetween November 2016 and November 2017, 30 consecutive patients (mean 68.8 ± 12.7 years, 6 female) with BTK lesions and CLI were included in this single-centre, prospective non-randomized cohort study. All patients with rest pain and/or ischemic wound associated with BTK lesions were included in the study. Mean lesion length was 133.6 ± 94.5 mm and 18(60%) were chronic total occlusions. The primary safety outcome parameter was a composite of all-cause mortality and major amputation at 6 months. The primary efficacy outcome parameter was the primary angiographic patency at 6 months (defined as freedom from clinically driven target lesion revascularization and the absence of significant restenosis (> 50%) as determined by core laboratory angiography assessment. Immediate technical success, late lumen loss (LLL), clinical target lesion revascularization (TLR) and ulcer healing rates at 12 months were also evaluated.

resultsImmediate technical success was 97%(29/30): one patient had an acute thrombosis at the completion of index procedure. Primary safety outcome parameter was 94%(28/30): one patient underwent major amputation and one patient died of other comorbidities at 2 months. Another patient had a major amputation at 7.5 months. Angiographic follow-up was available in 20 patients. Primary angiographic patency was 57%(12/21 lesions), and LLL was 0.99 ± 0.68 mm at 6 months. Freedom from TLR was 89% at 12 months. The rate of ulcer healing was 76% at 12 months.

conclusionRanger DCB balloons to treat CLI patients demonstrated a positive trend with good safety outcomes parameters. Further randomized studies are needed to understand the usefulness compared to POBA.

Indexed as

Coated Materials, BiocompatibleAgedAngioplasty, BalloonAntineoplastic Agents, PhytogenicCohort StudiesFemaleHumansIschemiaLimb SalvageMalePaclitaxelPopliteal ArteryProspective StudiesTime FactorsTreatment OutcomeVascular Surgical ProceduresAntineoplastic Agents, PhytogenicCoated Materials, BiocompatiblePaclitaxelBelow the kneeCritical limb ischemiaDrug eluting ballons

Identifiers

PMID33948700
OpenAlexW3157279407

What OpenQuestion holds

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Read underepoch 390

Registered trials

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.