RECO Flow Restoration Device Versus Solitaire FR With the Intention for Thrombectomy Study (REDIRECT): a prospective randomized controlled trial

OBJECTIVEThe RECO flow restoration (FR) device is a new stent retriever designed for rapid flow restoration in acute ischemic stroke (AIS) caused by large vessel occlusion (LVO). Here, the authors compared the efficacy and safety of the RECO device with the predicate Solitaire FR stent retriever.METHODSThe RECO Flow Restoration Device Versus Solitaire FR With the Intention for Thrombectomy Study (REDIRECT) was a multicenter, prospective, open randomized controlled trial. Patients with acute LVO at 7 Chinese stroke centers participated in the study. The primary efficacy endpoint was defined as a modified thrombolysis in cerebral infarction (mTICI) reperfusion grade ≥ 2 within three passes. The primary safety endpoint comprised any serious adverse device effect, symptomatic intracerebral hemorrhage (sICH), and any serious adverse event (SAE; defined as cerebral palsy or death) within 24 hours after the procedure. The secondary efficacy endpoints consisted of functional independence (modified Rankin Scale score 0–2), procedure duration, and 90-day all-cause mortality.RESULTSBetween January 2014 and August 2016, 67 patients were randomly allocated to the RECO group and 69 patients to the Solitaire FR group. The primary efficacy endpoint (mTICI grade ≥ 2 within three passes) was similar in the two treatment groups (91% vs 87%, respectively, p = 0.5861), and the rate of reperfusion with an mTICI grade 2b/3 was 87% versus 75% (p = 0.1272). There were no serious adverse device effects in any patient. The rates of sICH (1.5% vs 7.2%, p = 0.1027) and SAEs (6.0% vs 1.4%, p = 0.2050) within 24 hours after the procedure were similar in the two treatment groups. There was no significant difference in the rate of functional independence (63% vs 46%, p = 0.0609) or 90-day all-cause mortality (13% vs 23%, p = 0.1848) or in procedure duration (85.39 ± 47.01 vs 89.94 ± 53.34 minutes, p = 0.5986) between the two groups.CONCLUSIONSThe RECO stent retriever is effective and safe as a mechanical thrombectomy device for AIS due to LVO.Clinical trial registration no.: NCT01983644 (clinicaltrials.gov)

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Histological examination of vascular damage caused by stent retriever thrombectomy devices

Journal of NeuroInterventional Surgery ◽

10.1136/neurintsurg-2015-011968 ◽

2015 ◽

Vol 8 (10) ◽

pp. 992-995 ◽

Cited By ~ 42

Author(s):

Daisuke Arai ◽

Akira Ishii ◽

Hideo Chihara ◽

Hiroyuki Ikeda ◽

Susumu Miyamoto

Keyword(s):

Histological Examination ◽

Carotid Arteries ◽

Stent Retriever ◽

Vascular Damage ◽

Vascular Injuries ◽

Intimal Thickening ◽

Histological Changes ◽

Flow Restoration ◽

Medial Thickening ◽

Solitaire Fr

Background and objectivesAlthough the recently marketed stent retriever thrombectomy devices have demonstrated a high recanalization rate and favorable clinical outcomes, there is a concern about the risks of intimal injuries when pulling out the stent in the unfolded position. In this study, the Solitaire Flow Restoration System and the Trevo retriever were used in a histopathological comparison of vascular injuries caused by stent retriever thrombectomy devices.MethodsRabbit carotid arteries were used in the experiments with stent retriever thrombectomy devices. Carotid artery samples were harvested either 1 or 2 weeks postoperatively for histological examination.ResultsHistological changes caused by the use of stent retriever thrombectomy devices were observed from the intimal to medial layers. With the Solitaire FR 4 mm, intimal and medial thickening was observed 1 week postoperatively, and progression of intimal thickening was observed 2 weeks postoperatively. The extent of intimal thickening tended to be greater with the Solitaire FR 6 mm than with the Solitaire FR 4 mm, but this difference was not significant. Compared with the Solitaire FR 4 mm, the Trevo had a significantly smaller area of intimal thickening.ConclusionsAlthough there are some differences among devices, results from this study indicate that stent retriever thrombectomy devices induce vascular damage that extends to the medial layer.

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Abstract TP12: Comparison of 3D Stent Retriever to Solitaire in Patients with Small Ischemic Cores: An Analysis of the Penumbra 3D Trial

Stroke ◽

10.1161/str.48.suppl_1.tp12 ◽

2017 ◽

Vol 48 (suppl_1) ◽

Author(s):

Adnan Siddiqui ◽

Donald Frei ◽

Albert J Yoo ◽

Ghita Soulimani ◽

Hope Buell ◽

...

Keyword(s):

Functional Outcomes ◽

Meta Analysis ◽

Analysis Data ◽

Functional Independence ◽

Stent Retriever ◽

The Novel ◽

Inclusion Criteria ◽

Aspiration System ◽

Randomized Controlled ◽

Scale 8

Introduction: A recent meta-analysis of four randomized controlled trials (RCTs) concluded that mechanical thrombectomy using Solitaire for large vessel ischemic stroke was effective with significantly reduced disability. Hypothesis: Our hypothesis was that treatment with the Penumbra Aspiration System and the novel 3D Stent Retriever would demonstrate similar angiographic and functional outcomes compared to use of Solitaire. Methods: The 3D trial was a RCT to compare the safety and effectiveness of the 3D Stent Retriever when used with the Penumbra Aspiration System (3D/PS) compared to the PS alone. Inclusion criteria for the 3D RCT included presentation with NIH Stroke Scale ≥ 8 and refractory to or not eligible for IV rtPA. Analysis compared reperfusion to mTICI 2b or 3 and functional independence (mRS 0-2 at 90 days) in a 3D Trial cohort with ASPECTS 8-10 vs the meta-analysis data reported by Campbell et al ( Stroke 2016). Results: One hundred four (104) of 198 patients met analysis criteria. Baseline ASPECTS (median [IQR]) were similar between the 3D Trial ASPECTS 8-10 cohort (3D/PS, PS, combined: 9 [8,10]) and Campbell group (9 [7,10]). Substantial reperfusion (mTICI 2b or 3) was experienced in 84.6% (44/52) of 3D/PS and 75.0% (39/52) of PS alone cases, similar to the Campbell group (76.6%). When both arms were pooled, results (79.8%) were also similar to Campbell. With regards to functional independence, both 3D cohorts and pooled trial results showed similar rates compared with Campbell (Figure). Conclusions: The novel 3D Stent Retriever + Penumbra System and the Penumbra Aspiration System alone showed similar reperfusion and functional outcomes compared to Solitaire.

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Surveillance AFter Extremity Tumor surgerY (SAFETY): A Protocol for an International Randomized Controlled Trial

10.31219/osf.io/2wjyk ◽

2018 ◽

Author(s):

Patricia Schneider ◽

Michelle Ghert

Keyword(s):

Ct Scan ◽

Chest Radiograph ◽

Controlled Trial ◽

Disease Recurrence ◽

Evidence Based ◽

Treatment Groups ◽

Randomized Controlled ◽

Extremity Sarcoma ◽

Chest Ct Scan

Title: Surveillance AFter Extremity Tumor surgerY International Randomized Controlled TrialShort Title: SAFETYMethodology: Multi-center, 2 x 2 factorial superiority randomized controlled trial (RCT).Coordinating Center: This study will be centrally coordinated by the Methods Center at the Center for Evidence-Based Orthopaedics (CEO) at McMaster University in Hamilton, Ontario Canada. Clinical Sites: We are expecting ten clinical sites to be involved in the pilot phase. Further sites will be recruited for the definitive phase.Primary Objectives: The overall objective is to determine the effect of surveillance strategy on patient survival after surgery for a soft-tissue sarcoma of the extremity by comparing the effectiveness of: A) a surveillance frequency of every three months vs. every six months; and B) CT scans vs. chest radiographs.Secondary Objectives: We will explore: A) the effects of the post-operative surveillance strategies on patient-important outcomes (patient anxiety, overall satisfaction and quality of life), oncologic outcomes (local recurrence- and metastasis-free survival) and treatment-related complications (chemotherapy- and thoracotomy-related complications); and B) the net costs of post-operative surveillance strategies and of metastasis treatment and treatment-related complications. Treatment Groups: This study will compare two surveillance frequencies (every three months vs. every six months) and two imaging modalities (CT scan vs. chest radiograph) for a total of four treatment groups: 1)Surveillance visit and chest CT scan every three months for two years;2)Surveillance visit and chest CT scan every six months for two years; 3)Surveillance visit and chest radiograph every three months for two years; or4)Surveillance visit and chest radiograph every six months for two years. Study Outcome: The primary outcome is overall survival at five years post-randomization. Follow-Up: Upon completion of the two-year intervention phase, study participants will be followed every six months for another three years. Sample Size: Pilot - 200 participants | Definitive - 830 participantsEstimated Study Duration: Pilot - September 2019 – January 2023 | Definitive - TBDSignificance: Following treatment for a primary extremity sarcoma, patients remain at risk for the development of local and systemic disease recurrence. Metastasis (distant recurrence) to the lung is the most frequent single location of disease recurrence in sarcoma patients, occurring in almost half of all patients. Therefore, careful post-operative surveillance is an integral element of patient care. However, the detection of metastases does not necessarily affect long-term survival and may negatively impact quality of life. Surveillance strategies have not been well researched and have been identified as the top research priority in the extremity sarcoma field. The SAFETY trial will provide the necessary evidence to develop evidence-based surveillance guidelines, and is poised to have a significant impact on the post-operative care and outcomes of extremity soft-tissue sarcoma patients.

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Efficacy and Safety of a Hyaluronic Acid–Containing Cream in the Treatment of Chronic, Venous, or Mixed-Origin Leg Ulcers: A Prospective, Multicenter Randomized Controlled Trial

WOUNDS A Compendium of Clinical Research and Practice ◽

10.25270/wnds/100521.01 ◽

2021 ◽

Vol 33 (11) ◽

pp. 285-295

Author(s):

Jacek Mikosinski ◽

Anna Di Landro ◽

Karolina Kasztalska-Kazmierczak ◽

Emilie Soriano ◽

Carol Caverzasio ◽

...

Keyword(s):

Hyaluronic Acid ◽

Controlled Trial ◽

Leg Ulcers ◽

Primary Efficacy ◽

Primary Efficacy Endpoint ◽

Efficacy And Safety ◽

Randomized Controlled ◽

Mixed Origin ◽

Chronic Leg Ulcers ◽

Topical Applications

Introduction. Topical applications of hyaluronic acid (HA)–containing formulations, based on the complex and vital role of HA in all stages of the wound-healing process, are routinely used with standard therapy to promote faster healing of chronic wounds. However, evidence to guide clinical decisions on the use of topical HA in the healing of vascular leg ulcers is limited. Objective. This study compared the efficacy and safety of topical application of a hyaluronic acid cream vs a neutral comparator (identical cream without HA) in treating subjects with chronic leg ulcers of vascular origin. Materials and Methods. This was a prospective, multicenter double-blind randomized controlled trial. One hundred sixty-eight subjects with chronic leg ulcers of venous or mixed (venous and arterial) origin were randomized to receive either topical applications of 0.2% HA cream or neutral comparator cream for a maximum of 20 weeks. The primary efficacy endpoint was complete ulcer healing (100% reepithelialization of the wound area centrally assessed at 20 weeks or before and confirmed 3 weeks later). In both groups, topical treatment was associated with standard therapy (ulcer cleansing and optimized compression). Results. The proportion of subjects with centrally assessed complete healing of the target ulcer that was confirmed 3 weeks later (primary efficacy endpoint) was substantially higher in the HA cream group (31.3%) than in the neutral cream group (14.8%; P =.009). Results in the full analysis, per protocol, and as assessed by the investigator were consistent with primary results. No significant difference in treatment effect was observed when subjects were stratified according to baseline ulcer size (≤20 cm2 or >20 cm2) regardless of topical treatment. Safety and tolerability were comparable between treatments. Conclusions. Treatment of subjects with chronic leg ulcers of venous or mixed origin with HA cream is safe, well tolerated, and results in a higher rate of healing than a neutral comparator cream.

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Three-dimensional evaluation of forced unilateral posterior crossbite correction in the mixed dentition: a randomized controlled trial

European Journal of Orthodontics ◽

10.1093/ejo/cjz054 ◽

2019 ◽

Vol 42 (4) ◽

pp. 415-425 ◽

Cited By ~ 1

Author(s):

Ola Sollenius ◽

Aljaž Golež ◽

Jasmina Primožič ◽

Maja Ovsenik ◽

Lars Bondemark ◽

...

Keyword(s):

Controlled Trial ◽

Three Dimensional ◽

Mixed Dentition ◽

Projection Area ◽

Treatment Groups ◽

Posterior Crossbite ◽

Randomized Controlled ◽

Normal Occlusion ◽

Treatment Changes ◽

Quad Helix

Summary Objectives The objectives of this study were to assess the three-dimensional (3D) treatment changes (palatal surface area and volume) of forced unilateral posterior crossbite correction using either quad-helix or removable expansion plate appliances in the mixed dentition, and to compare the treatment changes with the three-dimensional changes occurring in age-matched untreated unilateral posterior crossbite patients as well as in subjects with normal occlusion and with no or mild orthodontic treatment need. Trial design Six-arm parallel group multicentre randomized controlled trial. Materials and methods One-hundred and thirty-five patients with unilateral posterior crossbite with functional shift were recruited. The patients were randomized by an independent person not involved in the trial. The randomization used blocks of 25, and the patients were randomized into the following five groups: quad-helix treatments in specialist orthodontic clinics (QHS), quad-helix treatments in general dentistry (QHG), removable expansion plate treatments in specialist orthodontic clinics (EPS), removable expansion plate treatments in general dentistry (EPG), and untreated crossbite (UC). Twenty-five patients with normal occlusion who served as normal controls were also included in the trial. Blinding of the outcome assessor and data analyst was accomplished. Data on all children were evaluated on an intention-to-treat basis, regarding 3D palatal surface area, palatal projection area, and palatal shell volume; two-dimensional linear measurements were registered at the same time. Results After treatment, the surface and projection area and shell volume increased in the four treatment groups (QHS, QHG, EPS, and EPG). QHS increased significantly more than EPG for the surface and projection area. The QHS and EPS had significantly higher mean difference for shell volume. Limitations The trial considers a short-term evaluation. Conclusion After treatment, there were no significant differences between the four treatment groups and the normal group, which implies that the surface and projection area together with the shell volume for the four treatment groups and the normal group were equivalent. Trial registration The trial was registered with https://www.researchweb.org/is/sverige, registration number: 220751.

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Treament and prevention of anemia with ferrous sulfate plus folic acid in children attending daycare centers in Goiânia, Goiás State, Brazil: a randomized controlled trial

Cadernos de Saúde Pública ◽

10.1590/s0102-311x2008001400011 ◽

2008 ◽

Vol 24 (suppl 2) ◽

pp. s259-s271 ◽

Cited By ~ 8

Author(s):

Maria Claret Costa Monteiro Hadler ◽

Dirce Maria Sigulem ◽

Maria de Fátima Costa Alves ◽

Vinícius Montenegro Torres

Keyword(s):

Folic Acid ◽

Ferrous Sulfate ◽

Controlled Trial ◽

Acid Group ◽

Hemoglobin Level ◽

Controlled Clinical Trial ◽

Double Blind ◽

Treatment Groups ◽

Daycare Centers ◽

Randomized Controlled

The objective of this study was to assess the prevalence of anemia and the therapeutic and prophylactic response to ferrous sulfate and folic acid. A double-blind, randomized, controlled clinical trial was conducted with 196 children 6 to 24 months of age enrolled in municipal daycare centers in Goiânia, Goiás State, Brazil. The children were assigned to two treatment groups that received a daily dose (5 times a week) of either 4.2mg/kg/day of ferrous sulfate + folic acid (50µg) or 4.2mg/kg/day of ferrous sulfate + folic acid placebo. One of the prevention groups received 1.4mg/kg/day of ferrous sulfate + folic acid (50µg/day) and the other 1.4mg/kg/day of ferrous sulfate + folic acid placebo. Supplementation lasted approximately three months. Baseline anemia prevalence was 56.1% (95%CI: 48.9-63.1). After treatment, anemia prevalence in the folic acid group (14%) was lower than in the placebo group (34.9%) (p = 0.02). After prophylaxis in the non-anemic children, the incidence of anemia did not differ between the groups, but there was an increase in hemoglobin level in the folic acid group (p = 0.003). Iron plus folic acid was effective for the treatment of anemia and improvement of hemoglobin level in non-anemic children.

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Mechanical thrombectomy in basilar artery occlusion: influence of reperfusion on clinical outcome and impact of the first-line strategy (ADAPT vs stent retriever)

Journal of Neurosurgery ◽

10.3171/2017.7.jns171043 ◽

2018 ◽

Vol 129 (6) ◽

pp. 1482-1491 ◽

Cited By ~ 34

Author(s):

Benjamin Gory ◽

Mikael Mazighi ◽

Raphael Blanc ◽

Julien Labreuche ◽

Michel Piotin ◽

...

Keyword(s):

Mechanical Thrombectomy ◽

Artery Occlusion ◽

Stent Retriever ◽

Favorable Outcome ◽

Basilar Artery Occlusion ◽

First Line ◽

All Cause Mortality ◽

Baseline Characteristics ◽

Procedure Duration ◽

Reperfusion Rate

OBJECTIVESeveral randomized trials have been focused on patients with anterior circulation stroke, whereas few data on posterior circulation stroke are available. Thus, new mechanical thrombectomy (MT) strategies, including a direct-aspiration first-pass technique (ADAPT), remain to be evaluated in basilar artery occlusion (BAO) patients. The authors here assessed the influence of reperfusion on outcome in BAO patients and examined whether ADAPT improves the reperfusion rate compared with stent retriever devices.METHODSThree comprehensive stroke centers prospectively collected individual data from BAO patients treated with MT. Baseline characteristics as well as radiographic and clinical outcomes were compared between the 2 MT strategies. The primary outcome measure was the rate of successful reperfusion, defined as a modified Thrombolysis in Cerebral Infarction (mTICI) grade of 2b–3. Favorable outcome was defined as a 90-day modified Rankin Scale score of 0–2.RESULTSAmong the 100 adult patients included in the study, 46 were treated with first-line ADAPT (median age 61 years, IQR 53–71 years; stent-retriever rescue therapy was secondarily used in 12 [26.1%]) and 54 were treated with a primary stent retriever (median age 67 years, IQR 53–78 years). There was no difference in baseline characteristics between the 2 treatment groups, except for the rate of diabetes (19.6% vs 5.7%, respectively, p = 0.035). Successful reperfusion was achieved in 79% of the overall study sample. Overall, the rate of favorable outcome was 36.8% and 90-day all-cause mortality was 44.2%. Successful reperfusion positively impacted favorable outcome (OR 4.57, 95% CI 1.24–16.87, p = 0.023). A nonsignificant trend toward a higher successful reperfusion rate (unadjusted OR 2.56, 95% CI 0.90–7.29, p = 0.071) and a significantly higher rate of complete reperfusion (mTICI grade 3; unadjusted OR 2.59, 95% CI 1.14–5.86, p = 0.021) was found in the ADAPT group. The procedure duration was also significantly lower in the ADAPT group (median 45 minutes, IQR 34 to 62 minutes vs 56 minutes, IQR 40 to 90 minutes; p = 0.05), as was the rate of periprocedural complications (4.3% vs 25.9%, p = 0.003). Symptomatic intracranial hemorrhage (0.0% vs 4.0%, p = 0.51) and 90-day all-cause mortality (46.7% vs 42.0%, p = 0.65) were similar in the 2 groups.CONCLUSIONSAmong BAO patients, successful reperfusion is a strong predictor of a 90-day favorable outcome, and the choice of ADAPT as the first-line strategy achieves a significantly higher rate of complete reperfusion with a shorter procedure duration.

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Electroacupuncture Versus Gabapentin for Hot Flashes Among Breast Cancer Survivors: A Randomized Placebo-Controlled Trial

Journal of Clinical Oncology ◽

10.1200/jco.2015.60.9412 ◽

2015 ◽

Vol 33 (31) ◽

pp. 3615-3620 ◽

Cited By ~ 55

Author(s):

Jun J. Mao ◽

Marjorie A. Bowman ◽

Sharon X. Xie ◽

Deborah Bruner ◽

Angela DeMichele ◽

...

Keyword(s):

Breast Cancer ◽

Cancer Survivors ◽

Breast Cancer Survivors ◽

Controlled Trial ◽

Hot Flashes ◽

Sham Acupuncture ◽

Treatment Groups ◽

Randomized Controlled ◽

Long Term Follow Up ◽

Nocebo Effects

Purpose Hot flashes are a common and debilitating symptom among survivors of breast cancer. This study aimed at evaluating the effects of electroacupuncture (EA) versus gabapentin (GP) for hot flashes among survivors of breast cancer, with a specific focus on the placebo and nocebo effects. Patients and Methods We conducted a randomized controlled trial involving 120 survivors of breast cancer experiencing bothersome hot flashes twice per day or greater. Participants were randomly assigned to receive 8 weeks of EA or GP once per day with validated placebo controls (sham acupuncture [SA] or placebo pills [PPs]). The primary end point was change in the hot flash composite score (HFCS) between SA and PP at week 8, with secondary end points including group comparisons and additional evaluation at week 24 for durability of treatment effects. Results By week 8, SA produced significantly greater reduction in HFCS than did PP (−2.39; 95% CI, −4.60 to −0.17). Among all treatment groups, the mean reduction in HFCS was greatest in the EA group, followed by SA, GP, and PP (−7.4 v −5.9 v −5.2 v −3.4; P = < .001). The pill groups had more treatment-related adverse events than did the acupuncture groups: GP (39.3%), PP (20.0%), EA (16.7%), and SA (3.1%), with P = .005. By week 24, HFCS reduction was greatest in the EA group, followed by SA, PP, and GP (−8.5 v −6.1 v −4.6 v −2.8; P = .002). Conclusion Acupuncture produced larger placebo and smaller nocebo effects than did pills for the treatment of hot flashes. EA may be more effective than GP, with fewer adverse effects for managing hot flashes among breast cancer survivors; however, these preliminary findings need to be confirmed in larger randomized controlled trials with long-term follow-up.

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