Trial reportClinical research in cardiology : official journal of the German Cardiac Society2017
Fractional flow reserve-guided coronary angioplasty using paclitaxel-coated balloons without stent implantation: feasibility, safety and 6-month results by angiography and optical coherence tomography.
Trial report in Clinical research in cardiology : official journal of the German Cardiac Society, 2017. 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 28 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.
Fractional Flow Reserve - Guided Elective Coronary Angioplasty Using Paclitaxel - Eluting Balloons With Provisional Stent Implantation: A Phase 4 Feasibility Study With 6-Month Follow-up by Optical Coherence Tomography
An Investigator-initiated, Multicenter, Open-label, Randomized Controlled Non-inferiority Trial to Assess the Single vs. Dual Antiplatelet Therapy in the Chronic Coronary Syndrome (CCS) and Stable Acute Coronary Syndrome (S-ACS) Patients Undergoing Percutaneous Intervention With Drug-coated Balloons (DCB)-Only Strategy (KONG-FREEDOM-I)
Who cites it
28 citing papers in PubMed, 2 syntheses or guidelines pooled it, 50 citations in OpenAlex.
- Drug coated balloon angioplasty for de novo coronary lesions in large vessels: a systematic review and meta-analysis.Scientific reports · 2025Pooled it
- Pooled it
- A multicenter randomized comparison of paclitaxel-coated balloon with plain balloon angioplasty in patients with small vessel disease.Clinical research in cardiology : official journal of the German Cardiac Society · 2017Trial
- Physiology-Guided Drug-Coated Balloon Angioplasty: What We Know and What is Yet to be Understood.Catheterization and cardiovascular interventions : official journal of the Society for Cardiac Angiography & Interventions · 2026Article
- Clinical application and expansion of paclitaxel-coated balloons in coronary atherosclerotic disease.World journal of cardiology · 2026Review
- Intravascular lithotripsy (IVL) facilitates drug-coated balloon (DCB) delivery and leads to favorable results in severely calcified coronary lesions without stenting.Clinical research in cardiology : official journal of the German Cardiac Society · 2026Observational
- Drug-Coated Balloons for Coronary Artery Disease: From Theory to Practice.Current treatment options in cardiovascular medicine · 2025Article
- Drug-Coated Balloons-Based Intervention for Coronary Artery Disease: The Second Report of Asia-Pacific Consensus Group.JACC. Asia · 2025Review
- Novel Applications of the Hybrid IVUS-OCT Imaging System: Suitable Lesions for Hybrid Imaging-Based Physiological Assessment.JACC. Asia · 2025Article
- Drug-Coated Balloon Treatment for De Novo Coronary Lesions: Current Status and Future Perspectives.Korean circulation journal · 2024Review
- Chinese expert consensus on the clinical application of drug-coated balloon (2Journal of geriatric cardiology : JGC · 2024Article
- Drug-Coated Balloon Treatment for Delayed Recanalization of Symptomatic Intracranial Artery Occlusion.Translational stroke research · 2023Article
- Clinical expert consensus document on drug-coated balloon for coronary artery disease from the Japanese Association of Cardiovascular Intervention and Therapeutics.Cardiovascular intervention and therapeutics · 2023Review
- Delayed stenosis regression after drug-coated balloon angioplasty for femoropopliteal artery lesions.Heart and vessels · 2022Article
- Prognostic Value of Coronary Angiography-Derived Fractional Flow Reserve Immediately After Stenting.Frontiers in cardiovascular medicine · 2022Article
- Drug-Coated Balloon for the Treatment of Nonacute Symptomatic Intracranial Carotid Artery Terminus Occlusion: Initial Experience and Follow-Up Outcome.Frontiers in neurology · 2022Article
- Clinical implication of quantitative flow ratio to predict clinical events after drug-coated balloon angioplasty in patients with in-stent restenosis.Clinical cardiology · 2021Article
- Impact of Arterial Remodeling of Intermediate Coronary Lesions on Long-Term Clinical Outcomes in Patients with Stable Coronary Artery Disease: An Intravascular Ultrasound Study.Journal of interventional cardiology · 2021Article
- Drug-coated balloon treatment in coronary artery disease: Recommendations from an Asia-Pacific Consensus Group.Cardiology journal · 2021Article
- 12-Month clinical results of drug-coated balloons for de novo coronary lesion in vessels exceeding 3.0 mm.The international journal of cardiovascular imaging · 2019Observational
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
6 authors at 1 institution in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundPercutaneous coronary interventions (PCI) with drug-coated balloons (DCB) might be a promising trade-off between balloon angioplasty and drug-eluting stents, since DCB inhibit neointimal proliferation and limit duration of dual antiplatelet therapy. We investigated the safety, feasibility, and 6-month results of fractional flow reserve (FFR)-guided use of the paclitaxel-coated SeQuent Please METHODS AND
resultsIn 46 patients (54 lesions) with stable symptomatic coronary artery disease (CAD), a FFR-guided POBA (plain old balloon angioplasty) was performed. In case of a sufficient POBA result with residual stenosis < 40 %, FFR > 0.8 and no severe dissection, the target lesion was finally dilated using the DCB. Quantitative coronary angiography (QCA) was performed before and after the index procedure and at 6-month follow-up (f/u) to calculate late lumen loss (LLL) and net luminal gain (NLG). Optical coherence tomography (OCT) was performed at f/u to assess vascular remodeling. DCB-only treatment was applied to 43 patients (51 lesions), while 3 patients (3 lesions) needed provisional stenting. Invasive f/u was completed in 39 patients (47 lesions). At the stenotic site, the lumen diameter showed a trend toward progressive increase at f/u (LLL: -0.13 ± 0.44 mm, n.s.; NLG: 1.10 ± 0.53 mm, p < 0.001) without aneurysm formation or restenosis after DCB-only treatment.
conclusionsFFR-guided DCB-only PCI of de novo lesions appeared feasible and safe in stable CAD with clopidogrel discontinuation after 4 weeks, showing a trend toward positive vessel remodeling without lumen loss at 6 months. Clinical trial registration http://www.clinicaltrials.gov . Unique identifier: NCT02120859.
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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.