PACE: randomized, controlled, multicentre, multinational, phase III study of PLX-PAD for critical limb ischaemia in patients unsuitable for revascularization: randomized clinical trial.
Lars NorgrenNorbert WeissSigrid NikolJohn C LantisManesh R PatelRobert J HinchliffeHolger ReineckeHans Dieter VolkPetra ReinkeGian Poalo FadiniRacheli OfirDaniel RothensteinNitsan HalevyMitko KaragjozovJohn H RundbackPublished in: The British journal of surgery (2024)
Although there was no evidence that PLX-PAD reduced amputation-free survival in the entire study population, benefit was observed in patients without diabetes mellitus or whose diabetes was well controlled; this requires confirmation in further studies. Trial registration: NCT03006770 (http://www.clinicaltrials.gov); 2015-005532-18 (EudraCT Clinical Trials register - Search for 2015-005532-18).
Keyphrases
- phase iii
- clinical trial
- end stage renal disease
- double blind
- open label
- phase ii
- ejection fraction
- newly diagnosed
- chronic kidney disease
- type diabetes
- free survival
- placebo controlled
- prognostic factors
- cardiovascular disease
- randomized controlled trial
- patient reported outcomes
- coronary artery disease
- metabolic syndrome
- coronary artery bypass grafting
- acute coronary syndrome
- adipose tissue
- patient reported
- peripheral artery disease