Self-expanding nitinol stents of high versus low chronic outward force in de novo femoropopliteal occlusive arterial lesions (BIOFLEX-COF trial): study protocol for a randomized controlled trial.

For example, indications that primary nitinol stenting is superior to balloon angioplasty and provisional stenting is based on solely three randomized control trials (RCTs) that showed superiority of primary stenting [ 3 – 5 ] and one RCT that showed a trend to increased patency in the stent group in short lesions [ 6 ].

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