PCB for Long De Novo Lesions of Main Coronary Arteries (D-Lesion Long Trial)
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|ClinicalTrials.gov Identifier: NCT03155971|
Recruitment Status : Unknown
Verified May 2017 by Zhilin Miao, The People's Hospital of Liaoning Province.
Recruitment status was: Not yet recruiting
First Posted : May 16, 2017
Last Update Posted : May 16, 2017
|Condition or disease||Intervention/treatment||Phase|
|Stable Angina Pectoris Unstable Angina Pectoris||Device: Paclitaxel-Coated Balloon||Not Applicable|
Paclitaxel-Coated Balloon Catheter is a new device in coronary disease, it can inhibit the proliferation of smooth muscle of coronary vessels by transitory contaction, without residual implantation.
More and more evidences have shown its efficacy and safety in diffuse small coronary disease, bifurcation disease and in-stent restenosis. But there are still seldom evidences in De Novo Lesions of Main Coronary Arteries.
PCB has used in some subgroup of many study but confused with in-stent renstenosis or small coronary disease. The investigators designed this study to evaluate the Efficacy and Safety of Paclitaxel-Coated Balloon Catheter in Patients With Diffuse Long De Novo Lesions of Main Coronary Arteries.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||60 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Efficacy and Safety of Paclitaxel-Coated Balloon Catheter in Patients With Long De Novo Lesions of Main Coronary Arteries|
|Estimated Study Start Date :||July 1, 2017|
|Estimated Primary Completion Date :||January 1, 2019|
|Estimated Study Completion Date :||February 1, 2019|
Experimental: PCB group
Prospective, single center, single-group clinical study. Interventions: Patients in the PCB group will be treated (angioplasted) with Paclitaxel-Coated Balloon (SeQuent ® Please; B.Braun, Melsungen, Germany)
Device: Paclitaxel-Coated Balloon
SeQuent ® Please; B.Braun, Melsungen, Germany
Other Name: Drug-coated balloon (DCB)
- QCA late lumen loss [ Time Frame: Immediately after the procedure and at 9 months follow-up ]minimal lumen diameter at post-procedure minus minimal lumen diameter at 9 months follow-up measured by QCA(quantitative coronary angiography)
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03155971
|Contact: Fei Xiafirstname.lastname@example.org|
|Contact: Zhilin Miaoemail@example.com|
|The People's Hospital of Liaoning Province||Not yet recruiting|
|Shenyang, Liaoning, China, 110016|
|Contact: Aijie Hou|
|Contact: Xizhuang Bai|
|Principal Investigator:||Aijie Hou||The People's Hospital of Liaoning Province|