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Journal of Vascular Surgery Nov 2015This report presents the 30-day results of the Safety and Efficacy Study for Reverse Flow Used During Carotid Artery Stenting Procedure (ROADSTER) multicenter trial and... (Clinical Trial)
Clinical Trial
OBJECTIVE
This report presents the 30-day results of the Safety and Efficacy Study for Reverse Flow Used During Carotid Artery Stenting Procedure (ROADSTER) multicenter trial and evaluates the safety and efficacy of ENROUTE Transcarotid NPS (Silk Road Medical Inc, Sunnyvale, Calif), a novel transcarotid neuroprotection system that provides direct surgical common carotid access and cerebral embolic protection via high-rate flow reversal during carotid artery stenting (CAS).
METHODS
A prospective, single-arm, multicenter clinical trial was performed to evaluate the use of the ENROUTE Transcarotid NPS during CAS procedures performed in patients considered to be at high risk for complications from carotid endarterectomy. Symptomatic patients with ≥50% stenosis and asymptomatic patients with ≥70% stenosis were eligible to be treated with any U.S. Food and Drug Administration-approved carotid artery stent. The primary end point was the composite of all stroke, myocardial infarction (MI), and death at 30 days postprocedure as defined in the Food and Drug Administration-approved study protocol. Secondary end points included cranial nerve injury; 30-day stroke, death, stroke/death, and MI; acute device, technical, and procedural success; and access site complications. All major adverse events were adjudicated by an independent clinical events committee.
RESULTS
Between November 2012 and July 2014, 208 patients were enrolled at 18 sites. Sixty-seven patients were enrolled as lead-in cases, and 141 were enrolled in the pivotal phase. In the pivotal cohort, 26% were symptomatic and 75% were asymptomatic. Acute device and technical success were 99% (140 of 141). By hierarchical analysis, the all-stroke rate in the pivotal group was 1.4% (2 of 141), stroke and death was 2.8% (4 of 141), and stroke, death and MI was 3.5% (5 of 141). One patient (0.7%) experienced postoperative hoarseness from potential Xth cranial nerve injury, which completely resolved at the 6-month follow-up visit.
CONCLUSIONS
The results of the ROADSTER trial demonstrate that the use of the ENROUTE Transcarotid NPS is safe and effective at preventing stroke during CAS. The overall stroke rate of 1.4% is the lowest reported to date for any prospective, multicenter clinical trial of CAS.
Topics: Adult; Aged; Aged, 80 and over; Angioplasty; Asymptomatic Diseases; Carotid Artery, Common; Carotid Stenosis; Cerebrovascular Circulation; Embolic Protection Devices; Female; Humans; Male; Middle Aged; Myocardial Infarction; Prospective Studies; Prosthesis Design; Regional Blood Flow; Risk Factors; Severity of Illness Index; Stents; Stroke; Time Factors; Treatment Outcome; United States
PubMed: 26506270
DOI: 10.1016/j.jvs.2015.04.460 -
JACC. Cardiovascular Interventions Sep 2022The comparative efficacy of percutaneous techniques for the preparation of calcified lesions before stenting remains poorly studied. (Randomized Controlled Trial)
Randomized Controlled Trial
BACKGROUND
The comparative efficacy of percutaneous techniques for the preparation of calcified lesions before stenting remains poorly studied.
OBJECTIVES
This study sought to compare the performance of up-front rotational atherectomy (RA) or balloon-based techniques before drug-eluting stent implantation in severely calcified coronary lesions as assessed by angiography and optical coherence tomography (OCT).
METHODS
Patient-level data from the PREPARE-CALC (Comparison of Strategies to Prepare Severely Calcified Coronary Lesions) and ISAR-CALC (Comparison of Strategies to Prepare Severely Calcified Coronary Lesions) randomized trials were pooled. The primary endpoint was stent expansion as assessed by OCT imaging. The secondary endpoints included stent eccentricity, stent asymmetry, angiographic acute lumen gain, strategy success and in-hospital occurrence of cardiac death, target vessel myocardial infarction, and repeat revascularization.
RESULTS
Among 274 patients originally randomized, 200 participants with available OCT data after lesion preparation with RA (n = 63), a modified balloon (MB, n = 103), or a super high-pressure balloon (n = 34) before stenting were analyzed. The use of RA versus MB or a super high-pressure balloon led to comparable stent expansion (73.2% ± 11.6% vs 70.8% ± 13.6% vs 71.8% ± 12.2%, P = 0.49) and stent asymmetry (P = 0.83). Compared with RA or MB, a super high-pressure balloon was associated with less stent eccentricity (P = 0.03) with a numerically higher acute lumen gain, albeit not significantly different (P = 0.08). Strategy success was more frequent with RA versus MB (P = 0.002) and numerically more frequent with RA versus a super high-pressure balloon (P = 0.06). Clinical outcomes did not differ between groups.
CONCLUSIONS
In patients with severely calcified lesions undergoing drug-eluting stent implantation, lesion preparation with RA, MB, or a super high-pressure balloon was associated with comparable stent expansion. A super high-pressure balloon is associated with less stent eccentricity, whereas strategy success is more frequent with RA.
Topics: Angioplasty, Balloon, Coronary; Atherectomy, Coronary; Coronary Angiography; Coronary Artery Disease; Drug-Eluting Stents; Humans; Treatment Outcome; Vascular Calcification
PubMed: 36137691
DOI: 10.1016/j.jcin.2022.07.034 -
The Journal of Invasive Cardiology May 2020Accordion effect or concertina effect - also known as "crumpled coronary" - is an uncommon occurrence during coronary angioplasty. It usually has no major clinical...
Accordion effect or concertina effect - also known as "crumpled coronary" - is an uncommon occurrence during coronary angioplasty. It usually has no major clinical sequelae and should be differentiated from spasm, dissection, and thrombosis, which require special management.
Topics: Angioplasty, Balloon, Coronary; Coronary Angiography; Humans
PubMed: 32357138
DOI: No ID Found -
AJNR. American Journal of Neuroradiology Nov 2017
Topics: Angioplasty, Balloon; Stents
PubMed: 29051206
DOI: 10.3174/ajnr.A5435 -
Circulation Feb 2015Drug-coated balloons (DCBs) have shown promise in improving the outcomes for patients with peripheral artery disease. We compared a paclitaxel-coated balloon with... (Randomized Controlled Trial)
Randomized Controlled Trial
Drug-coated balloon versus standard percutaneous transluminal angioplasty for the treatment of superficial femoral and popliteal peripheral artery disease: 12-month results from the IN.PACT SFA randomized trial.
BACKGROUND
Drug-coated balloons (DCBs) have shown promise in improving the outcomes for patients with peripheral artery disease. We compared a paclitaxel-coated balloon with percutaneous transluminal angioplasty (PTA) for the treatment of symptomatic superficial femoral and popliteal artery disease.
METHODS AND RESULTS
The IN.PACT SFA Trial is a prospective, multicenter, single-blinded, randomized trial in which 331 patients with intermittent claudication or ischemic rest pain attributable to superficial femoral and popliteal peripheral artery disease were randomly assigned in a 2:1 ratio to treatment with DCB or PTA. The primary efficacy end point was primary patency, defined as freedom from restenosis or clinically driven target lesion revascularization at 12 months. Baseline characteristics were similar between the 2 groups. Mean lesion length and the percentage of total occlusions for the DCB and PTA arms were 8.94 ± 4.89 and 8.81 ± 5.12 cm (P=0.82) and 25.8% and 19.5% (P=0.22), respectively. DCB resulted in higher primary patency versus PTA (82.2% versus 52.4%; P<0.001). The rate of clinically driven target lesion revascularization was 2.4% in the DCB arm in comparison with 20.6% in the PTA arm (P<0.001). There was a low rate of vessel thrombosis in both arms (1.4% after DCB and 3.7% after PTA [P=0.10]). There were no device- or procedure-related deaths and no major amputations.
CONCLUSIONS
In this prospective, multicenter, randomized trial, DCB was superior to PTA and had a favorable safety profile for the treatment of patients with symptomatic femoropopliteal peripheral artery disease.
CLINICAL TRIAL REGISTRATION URL
http://www.clinicaltrials.gov. Unique Identifiers: NCT01175850 and NCT01566461.
Topics: Aged; Angioplasty; Angioplasty, Balloon; Female; Femoral Artery; Humans; Internationality; Male; Middle Aged; Peripheral Arterial Disease; Popliteal Artery; Prospective Studies; Single-Blind Method; Time Factors; Treatment Outcome; Vascular Access Devices
PubMed: 25472980
DOI: 10.1161/CIRCULATIONAHA.114.011004 -
Journal of Vascular Surgery Jan 2015
Topics: Angioplasty; Carotid Artery, External; Carotid Artery, Internal; Carotid Stenosis; Endarterectomy, Carotid; Humans; Stents
PubMed: 25064528
DOI: 10.1016/j.jvs.2014.06.011 -
JACC. Cardiovascular Interventions Mar 2017
Topics: Angioplasty, Balloon, Coronary; Cardiac Catheters; Coronary Artery Bypass; Coronary Artery Disease; History, 20th Century; Humans; Risk Factors; Smoking; Time Factors; Treatment Outcome
PubMed: 28279324
DOI: 10.1016/j.jcin.2017.02.001 -
Journal of Vascular Surgery Jul 2014
Topics: Aneurysm; Angioplasty; Female; Humans; Male; Renal Artery
PubMed: 24594446
DOI: 10.1016/j.jvs.2014.01.074 -
The Journal of Cardiovascular Surgery Aug 2018Percutaneous transluminal angioplasty and stenting is becoming increasingly the first-line treatment for patients with both claudication and critical limb ischemia... (Review)
Review
Percutaneous transluminal angioplasty and stenting is becoming increasingly the first-line treatment for patients with both claudication and critical limb ischemia instead of surgery, with the aim of returning the patient's quality of life in the former and preventing amputation. Drug-eluting technologies have seen a large surge in popularity in recent years, and significant patient benefits have been seen with the use of drug-eluting stents and balloons over the use of plain balloon angioplasty. Unfortunately, in many patients with arterial disease there is significant vessel wall calcification - this can theoretically be a barrier to drug delivery and can also be a contributing factor to flow limiting dissection and the subsequent need for bail out stenting. Several studies have looked at the efficacy of scoring balloons to minimize these problems in patients with severe calcification. With increasing use of vascular stents over the last 5-10 years, more cases of in stent stenosis are being seen, and scoring balloons have been postulated to improve outcomes here also. Scoring balloons have been available for many years, having seen first use in the coronary system, but are now being studied in the peripheral arterial landscape, both above and below the popliteal segment. This article will review their use in the superficial femoral artery.
Topics: Angioplasty; Angioplasty, Balloon; Coated Materials, Biocompatible; Equipment Design; Femoral Artery; Humans; Peripheral Arterial Disease; Vascular Access Devices
PubMed: 29786412
DOI: 10.23736/S0021-9509.18.10574-X -
JACC. Cardiovascular Interventions Feb 2020
Topics: Angioplasty, Balloon; Popliteal Artery; Treatment Outcome
PubMed: 32081237
DOI: 10.1016/j.jcin.2019.12.007