Trial reportCatheterization and cardiovascular interventions : official journal of the Society for Cardiac Angiography & Interventions2018
Stellarex drug-coated balloon for treatment of femoropopliteal arterial disease-The ILLUMENATE Global Study: 12-Month results from a prospective, multicenter, single-arm study.
Trial report in Catheterization and cardiovascular interventions : official journal of the Society for Cardiac Angiography & Interventions, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04137614 (The Effects and Safety of Drug-coated Balloon in the Treatment of Hypertension Caused by Takayasu Arteritis Associated Renal Artery Stenosis), which is not on this map. Cited by 13 papers, 1 of them a synthesis that pooled 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.
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.
The Effects and Safety of Drug-coated Balloon in the Treatment of Hypertension Caused by Takayasu Arteritis Associated Renal Artery Stenosis: a Single Centre, Random, Double Blind Trial
Who cites it
13 citing papers in PubMed, 1 synthesis or guideline pooled it, 45 citations in OpenAlex.
- Mortality Assessment of Paclitaxel-Coated Balloons: Patient-Level Meta-Analysis of the ILLUMENATE Clinical Program at 3 Years.Circulation · 2019Pooled it
- Five-Year Outcomes after Paclitaxel Drug-Coated Balloon Treatment of Femoropopliteal Lesions in Diabetic and Chronic Limb-Threatening Ischemia Cohorts: IN.PACT Global Study Post Hoc Analysis.Cardiovascular and interventional radiology · 2023Trial
- Three-Year Results of the IN.PACT SFA Japan Trial Comparing Drug-Coated Balloons With Percutaneous Transluminal Angioplasty.Journal of endovascular therapy : an official journal of the International Society of Endovascular Specialists · 2020Trial
- Three-Year Sustained Clinical Efficacy of Drug-Coated Balloon Angioplasty in a Real-World Femoropopliteal Cohort.Journal of endovascular therapy : an official journal of the International Society of Endovascular Specialists · 2020Trial
- IN.PACT SFA Clinical Study Using the IN.PACT Admiral Drug-Coated Balloon in a Chinese Patient Population.Journal of endovascular therapy : an official journal of the International Society of Endovascular Specialists · 2019Trial
- Stellarex drug-coated balloon for treatment of femoropopliteal arterial disease-The ILLUMENATE Global Study: 12-Month results from a prospective, multicenter, single-arm study.Catheterization and cardiovascular interventions : official journal of the Society for Cardiac Angiography & Interventions · 2018Trial
- Intraoperative Extravascular Ultrasound in the Identification of Flow-Limiting Dissections after Balloon Angioplasty in the Femoropopliteal Segment.Journal of clinical medicine · 2024Article
- Drug-Coated Balloon versus Drug-Eluting Stent: The Debate of Leave Nothing Behind.Seminars in interventional radiology · 2023Review
- Long-term outcomes after paclitaxel-coated balloon angioplasty of femoropopliteal arteries in Asian patients of the IN.PACT Global Study.Catheterization and cardiovascular interventions : official journal of the Society for Cardiac Angiography & Interventions · 2022Article
- Paclitaxel-Coated Balloon Angioplasty for the Treatment of Infrainguinal Arteries: 24-Month Outcomes in the Full Cohort of BIOLUX P-III Global Registry.Cardiovascular and interventional radiology · 2021Observational
- Endovascular balloon angioplasty for infrainguinal arterial occlusive disease: Efficacy analysis.Turk gogus kalp damar cerrahisi dergisi · 2021Article
- Paclitaxel-Coated Balloon for the Treatment of Infrainguinal Disease: 12-Month Outcomes in the All-Comers Cohort of BIOLUX P-III Global Registry.Journal of endovascular therapy : an official journal of the International Society of Endovascular Specialists · 2020Observational
- What are the Pathological Concerns and Limitations of Current Drug-coated Balloon Technology?Heart international · 2019Review
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
12 authors at 11 institutions in 7 countries.
Funding
No grant is acknowledged in the PubMed record.
Abstract
objectivesThe purpose of this study was to assess the safety and performance of Stellarex Drug-coated balloon (DCB).
backgroundDCB coatings differ in excipients, paclitaxel dose, and coating morphologies. Due to these differences, a class effect with DCBs has not been demonstrated. Consequently, each DCB needs to be evaluated independently based on its own clinical study results.
methodsThe ILLUMENATE Global Study is a prospective, multicenter, single-arm study. Patients with intermittent claudication or ischemic rest pain due to superficial femoral artery (SFA) and/or popliteal peripheral artery disease (PAD) were treated with the Stellarex DCB. The primary efficacy endpoint was primary patency, defined as freedom from restenosis with peak systolic velocity ratio ≤2.5 or clinically-driven target lesion revascularization (CD-TLR) at 12 months. The primary safety endpoint was freedom from device and procedure-related death through 30 days postprocedure and freedom from target limb major amputation and CD-TLR through 12 months.
resultsIn total, 417 lesions were treated in 371 patients. The mean lesion length was 7.5 ± 5.3 cm, 40.8% of lesions were severely calcified per core laboratory fluoroscopy criteria and 31.3% were total occlusions. Primary patency by independent duplex core lab evaluation was 81.4% and the freedom from CD-TLR was 94.8% day 365 per Kaplan-Meier estimate. The majority of patients experienced improvements in their Rutherford classification (90.3%) and walking impairment questionnaire score (83.6%) at 12 months compared to baseline.
conclusionsThis study validated previous positive findings and confirms the strong safety profile and effectiveness outcomes.
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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.