TY - JOUR
T1 - A prospective multicenter randomized trial to assess the effectiveness of the magic touch sirolimus-coated balloon in small vessels: Rationale and design of the TRANSFORM I trial
AU - Ono, Masafumi
AU - Kawashima, Hideyuki
AU - Hara, Hironori
AU - Katagiri, Yuki
AU - Takahashi, Kuniaki
AU - Kogame, Norihiro
AU - Wykrzykowska, Joanna J.
AU - Piek, Jan J.
AU - Doshi, Manish
AU - Sharif, Faisal
AU - Onuma, Yoshinobu
AU - Colombo, Antonio
AU - Serruys, Patrick W.
AU - Cortese, Bernardo
PY - 2021/4
Y1 - 2021/4
N2 - Aims: The objective of the study is to assess the efficacy and safety of the novel Magic Touch sirolimus coated-balloon (SCB) when compared to the SeQuent Please Neo paclitaxel coated balloon (PCB) for the treatment of de-novo small vessel coronary artery diseases (SVD). Study design: The TRANSFORM I study is a randomized, multicenter, non-inferiority trial with the intent to enroll a total of 114 patients with a de-novo SVD (≤2.5 mm). Vessel size will be pre-screened by on-line QCA. After successful pre-dilatation without major coronary dissections (type C-F) nor Thrombolysis In Myocardial Infarction trial [TIMI] grade flow ≤2, patients will be enrolled in a 1:1 randomization to receive treatment with either the novel SCB balloon or the comparative PCB balloon. The balloon sizing will be selected according to the lumen-based approach derived from optical coherence tomography (OCT). The primary endpoint is 6-month mean net lumen diameter gain (6-month minimum lumen diameter [MLD] minus baseline MLD) assessed by quantitative coronary analysis (QCA) with non-inferiority margin of 0.3 mm in per-protocol analysis. The clinical follow-up will be conducted up to 1 year. The enrollment started in September 2020 and will complete in April 2021. Conclusions: The TRANSFORM I trial will assess the efficacy of novel SCB in terms of non-inferiority to conventional PCB with a novel OCT measurement approach in patients with a de-novo SVD. Clinical Trial Registration URL: https://clinicaltrials.gov. Unique identifier: NCT03913832.
AB - Aims: The objective of the study is to assess the efficacy and safety of the novel Magic Touch sirolimus coated-balloon (SCB) when compared to the SeQuent Please Neo paclitaxel coated balloon (PCB) for the treatment of de-novo small vessel coronary artery diseases (SVD). Study design: The TRANSFORM I study is a randomized, multicenter, non-inferiority trial with the intent to enroll a total of 114 patients with a de-novo SVD (≤2.5 mm). Vessel size will be pre-screened by on-line QCA. After successful pre-dilatation without major coronary dissections (type C-F) nor Thrombolysis In Myocardial Infarction trial [TIMI] grade flow ≤2, patients will be enrolled in a 1:1 randomization to receive treatment with either the novel SCB balloon or the comparative PCB balloon. The balloon sizing will be selected according to the lumen-based approach derived from optical coherence tomography (OCT). The primary endpoint is 6-month mean net lumen diameter gain (6-month minimum lumen diameter [MLD] minus baseline MLD) assessed by quantitative coronary analysis (QCA) with non-inferiority margin of 0.3 mm in per-protocol analysis. The clinical follow-up will be conducted up to 1 year. The enrollment started in September 2020 and will complete in April 2021. Conclusions: The TRANSFORM I trial will assess the efficacy of novel SCB in terms of non-inferiority to conventional PCB with a novel OCT measurement approach in patients with a de-novo SVD. Clinical Trial Registration URL: https://clinicaltrials.gov. Unique identifier: NCT03913832.
KW - Drug-coated balloon
KW - Optical coherence tomography
KW - Randomized trial
KW - Sirolimus-coated balloon
KW - Small vessel disease
UR - https://www.scopus.com/inward/record.uri?partnerID=HzOxMe3b&scp=85093962692&origin=inward
UR - https://www.ncbi.nlm.nih.gov/pubmed/33109476
U2 - https://doi.org/10.1016/j.carrev.2020.10.004
DO - https://doi.org/10.1016/j.carrev.2020.10.004
M3 - Article
C2 - 33109476
SN - 1553-8389
VL - 25
SP - 29
EP - 35
JO - Cardiovascular Revascularization Medicine
JF - Cardiovascular Revascularization Medicine
ER -