Clinical Endpoints in Peripheral Endovascular Revascularization Trials: a Case for Standardized Definitions

Diehm, Nicolas; Pattynama, Peter M. T.; Jaff, Michael R.; Cremonesi, Alberto; Becker, Gary J.; Hopkins, L. Nelson; Mahler, F; Talen, Aly; Cardella, John F.; Ramee, Stephen R.; Sambeek, Marc van; Vermassen, Frank; Biamino, Giancarlo

doi:10.1016/j.ejvs.2008.06.020

Cited by 124 publications

(50 citation statements)

References 25 publications

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“…20 The DEFINE Group proposed appropriate endpoints such as sustained clinical improvement/deterioration based on Rutherford stage, hemodynamic improvement by ABPI, mortality and need for unplanned amputations for endovascular interventions in patients with CLI. 21 The Society for Vascular Surgery proposed objective performance goals for bypass surgery in CLI: major amputation or any major vascular re-intervention defined as major adverse limb event (MALE) and freedom from perioperative death or any MALE (MALE+POD) as key endpoints for revascularization therapy. 22 No guidelines of clinical trial endpoints, however, have been proposed for cellular therapy in CLI.…”

Section: Discussionmentioning

confidence: 99%

Phase II Clinical Trial of CD34+ Cell Therapy to Explore Endpoint Selection and Timing in Patients With Critical Limb Ischemia

Fujita

Kinoshita

Furukawa

et al. 2014

Circ J

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Section: Discussionmentioning

confidence: 99%

Phase II Clinical Trial of CD34+ Cell Therapy to Explore Endpoint Selection and Timing in Patients With Critical Limb Ischemia

Fujita

Kinoshita

Furukawa

et al. 2014

Circ J

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“…The ABI and the claudication status are also determined (Rutherford clinical classes and Fontaine stages) at all followup intervals. Patency was defi ned as diameter stenosis < 50 % according to recommended reporting standards [6].…”

Section: Secondary Endpointsmentioning

confidence: 99%

First clinical experience with the Multi-LOC multiple stent delivery system for focal stenting in long femoro-popliteal lesions

Amendt

Beschorner

Waliszewski

et al. 2017

Vasa

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Background:The purpose of this observational study is to report the six-month clinical outcomes with a new multiple stent delivery system in patients with femoro-popliteal lesions. Patients and methods: The LOCOMOTIVE study is an observational multicentre study with a primary endpoint target lesion revascularization (TLR) rate at six months. Femoro-popliteal lesions were prepared with uncoated and/or paclitaxel-coated peripheral balloon catheters. When fl ow limiting dissections, elastic recoil or recoil due to calcifi cation required stenting, up to six short stents per delivery device, each 13 mm in length, were implanted. Sonographic follow-ups and clinical assessments were scheduled at six months. Results: For this fi rst analysis, a total of 75 patients 72.9 ± 9.2 years of age were enrolled. The majority of the 176 individually treated lesions were in the superfi cial femoral artery (76.2 %, 134/176) whereas the rate of TASC C/D amounted to 51.1 % (90/176). The total lesion length was 14.5 ± 9.0 cm with reference vessel diameters of 5.6 ± 0.7 mm. Overall 47 ± 18 % of lesion lengths could be saved from stenting. At six months, the patency was 90.7 % (68/75) and all-cause TLR rates were 5.3 % (4/75) in the overall cohort. Conclusions: The fi rst clinical experience at six months suggests that the MSDS strategy was safe and effective to treat femoro-popliteal lesions of considerable length (14.5 ± 9.0 cm). Almost half of the lesion length could be saved from stenting while patency was high and TLR rates were acceptably low.

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“…10,20 The degree of lesion calcification was classified using the Peripheral Academic Research Consortium criteria. 10,21 FA failure was defined as the need to switch to the contralateral femoral artery for any reason to complete the procedure; TRA failure was confirmed if lesion crossing was not achieved and any form of alternative access was required to complete the procedure.…”

Section: Definitionsmentioning

confidence: 99%

Comparison of Transradial vs Transfemoral Access for Aortoiliac and Femoropopliteal Interventions

et al. 2016

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Purpose: To compare the procedure and safety outcomes of the transradial approach (TRA) with the femoral approach (FA) for treating aortoiliac and femoropopliteal stenoses and occlusions. Methods: A single-center retrospective study was conducted involving 188 patients (mean age 66.4±10.8 years; 116 men) with lower limb claudication or critical limb ischemia who underwent aortoiliac (131, 62.4%) or femoropopliteal (79, 37.6%) interventions on 210 lesions over a 3-year period. Operator discretion determined TRA suitability; exclusions included Raynaud’s disease, upper limb occlusive disease, previous TRA difficulties, or planned hemodialysis. Lesion characteristics, clinical endpoints, and access site complications were compared. Results: FA was used primarily in 123 patients and the TRA (12 left and 53 right radial arteries) in 65 procedures. Eleven (16.9%) TRAs failed vs 9 (7.3%) FAs (p=0.42). Crossover to FA was due to occlusive lesions requiring alternative equipment in 9 cases and to tortuosity of the aortic arch vessels in 2 patients. The 134 FA interventions (balloon angioplasty, stents) were retrograde (112, 83.6%) or antegrade (22, 16.4%). There were significantly more TASC C/D lesions in the FA group (p=0.02). Sheath sizes (5-F to 8-F) did not differ between groups, and no significant differences were found between FA vs TRA in terms of procedure time (50.0±28.9 vs 46.8±25.1 minutes, p=0.50) or length of stay (2.2±0.6 vs 2.1±0.3 days, p=0.24). While there were no strokes, access site complications occurred in 6.0% of the FA patients vs 3.7% of the TRA patients (p=0.12). Conclusion: The transradial approach for aortoiliac and femoropopliteal interventions is safe and efficacious compared with the transfemoral approach for a range of lesion subtypes. Nevertheless, there remains a need for improvements in peripheral device and catheter technology to decrease transradial failure rates.

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Clinical Endpoints in Peripheral Endovascular Revascularization Trials: a Case for Standardized Definitions

Cited by 124 publications

References 25 publications

Phase II Clinical Trial of CD34+ Cell Therapy to Explore Endpoint Selection and Timing in Patients With Critical Limb Ischemia

Phase II Clinical Trial of CD34+ Cell Therapy to Explore Endpoint Selection and Timing in Patients With Critical Limb Ischemia

First clinical experience with the Multi-LOC multiple stent delivery system for focal stenting in long femoro-popliteal lesions

Comparison of Transradial vs Transfemoral Access for Aortoiliac and Femoropopliteal Interventions

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