Trial reportJournal of endovascular therapy : an official journal of the International Society of Endovascular Specialists2018
Safety and Feasibility of Intravascular Lithotripsy for Treatment of Below-the-Knee Arterial Stenoses.
Trial report in Journal of endovascular therapy : an official journal of the International Society of Endovascular Specialists, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 2 registered trials, which are not on this map. Cited by 34 papers, 2 of them syntheses that pooled it.
What it found
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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.
Safety and Feasibility of the Shockwave Lithoplasty® System for the Treatment of Peripheral Vascular Stenosis
Shockwave Induced Attenuation of Calcified Plaques Quantified With OCT
Who cites it
34 citing papers in PubMed, 2 syntheses or guidelines pooled it.
- Vessel Preparation in Infrapopliteal Arterial Disease: A Systematic Review and Meta-Analysis.Journal of endovascular therapy : an official journal of the International Society of Endovascular Specialists · 2024Pooled it
- SCAI guidelines on device selection in Aorto-Iliac arterial interventions.Catheterization and cardiovascular interventions : official journal of the Society for Cardiac Angiography & Interventions · 2020Guideline
- Device design and applications of the novel JAVELIN peripheral intravascular lithotripsy catheter.Journal of vascular surgery cases and innovative techniques · 2026Article
- Intravascular Lithotripsy for Peripheral Artery Calcification: 30-Day Outcomes From the Disrupt PAD III Observational Study.Journal of endovascular therapy : an official journal of the International Society of Endovascular Specialists · 2026Observational
- Intravascular lithotripsy of the femoropopliteal arteries: analysis of a prospective two-center pilot study.Postepy w kardiologii interwencyjnej = Advances in interventional cardiology · 2026Article
- Intravascular Lithotripsy for Peripheral Arterial Disease: Outcomes From a Single-Center Experience.Cureus · 2026Article
- Calcium Modification During Peripheral Intervention With a Novel Intravascular Lithotripsy System: An Institutional Experience.Journal of the Society for Cardiovascular Angiography & Interventions · 2025Article
- Overview of Therapeutic Ultrasound Applications and Safety Considerations: 2024 Update.Journal of ultrasound in medicine : official journal of the American Institute of Ultrasound in Medicine · 2025Review
- Benefits and Challenges of Drug-Coated Balloons in Peripheral Artery Disease: From Molecular Mechanisms to Clinical Practice.International journal of molecular sciences · 2024Review
- Current Status of and Future Prospects for Drug-Eluting Stents and Scaffolds in Infrapopliteal Arteries.Journal of clinical medicine · 2024Review
- Surgical and Endovascular Therapies for Below-the-Knee Peripheral Arterial Disease: A Contemporary Review.Journal of the Society for Cardiovascular Angiography & Interventions · 2024Review
- Outcomes of Intravascular Lithotripsy in the Treatment of Chronic Limb-Threatening Ischemia: A Single-Center Retrospective Study.Cardiovascular and interventional radiology · 2023Article
- Scoping review of atherectomy and intravascular lithotripsy with or without balloon angioplasty in below-the-knee lesions.Journal of vascular surgery cases and innovative techniques · 2023Article
- Treatment of Difficult, Calcified Lesions: Plaque Modification Strategies.Seminars in interventional radiology · 2023Review
- Human Cadaveric Model for Vessel Preparation Device Testing in Calcified Tibial Arteries.Journal of cardiovascular translational research · 2023Article
- Intravascular Lithotripsy and Drug-Coated Balloon Angioplasty for Severely Calcified Femoropopliteal Arterial Disease.Journal of endovascular therapy : an official journal of the International Society of Endovascular Specialists · 2023Article
- Medial artery calcification in peripheral artery disease.Frontiers in cardiovascular medicine · 2023Review
- Cardiovascular Disease Management in the Context of Global Crisis.International journal of environmental research and public health · 2022Article
- Atherectomy vs Other Modalities for Treatment During Peripheral Vascular Intervention.Current cardiology reports · 2022Review
- Calcific Plaque Modification by Acoustic Shockwaves: Intravascular Lithotripsy in Cardiovascular Interventions.Current cardiology reports · 2022Review
Corrections and comments
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Authors and funding
3 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
purposeTo evaluate the safety and feasibility of treating calcified infrapopliteal stenoses using an intravascular lithotripsy (IVL) system.
methodsThe Disrupt BTK study was a prospective, nonrandomized, multicenter, feasibility, and safety trial that enrolled 20 patients (mean age 79.0±9.6 years; 14 men) at 3 participating sites ( ClinicalTrials.gov identifier NCT02911623). Fifteen patients had Rutherford category 5 ischemia, and all patients had moderate to severe below-the-knee arterial calcification. Patients were treated with the Shockwave Medical Peripheral IVL System and followed for 30 days. The primary safety endpoint was a composite of major adverse events through 30 days defined as death, myocardial infarction, need for emergency surgical revascularization of the target limb, or amputation of the target limb. The primary effectiveness outcome was acute reduction in the percent diameter stenosis.
resultsIVL catheter delivery was successful in 19 patients. The composite of major adverse events at 30 days was 0%. The acute reduction in percent diameter stenosis of target lesions was 46.5%. All patients achieved residual diameter stenosis ≤50%. Vascular complications were minimal with only 1 type B dissection reported and 2 stents placed. None of the subjects experienced thrombus formation, abrupt closure, distal embolization, or perforation. There were no device-related complications.
conclusionThe early results of this pilot study demonstrated that calcified, stenotic infrapopliteal arteries can be safely and successfully treated with intravascular lithotripsy.
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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.