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PCB for Long De Novo Lesions of Main Coronary Arteries (D-Lesion Long Trial)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
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
Sponsor:
Information provided by (Responsible Party):
Zhilin Miao, The People's Hospital of Liaoning Province

Brief Summary:
This study evaluates the Efficacy and Safety of Paclitaxel-Coated Balloon Catheter in Patients With Diffuse Long De Novo Lesions of Main Coronary Arteries.

Condition or disease Intervention/treatment Phase
Stable Angina Pectoris Unstable Angina Pectoris Device: Paclitaxel-Coated Balloon Not Applicable

Detailed Description:

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine

Drug Information available for: Paclitaxel

Arm Intervention/treatment
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)




Primary Outcome Measures :
  1. 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)



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. a diagnosis of stable angina or unstable angina in hospitalized patients. Objective clinical evidence of ischemia (ECT, Exercise ECG, ECG ST-T changes) With CAG proven one vessel lesion(a lesion length of ≥ 20mm);
  2. a lesion diameter stenosis >75% as evaluated by QCA with a reference diameter of ≥ 2.75 mm and ≤ 3.5 mm .
  3. a willingness or ability to provide informed consent,a willingness to receive telephone followed-up at postoperative 1 month, 3 month, 6 month, and an angiographic follow up at postoperative 9 month.
  4. a willingness to receive DCB angioplast or DES implantation.

Exclusion Criteria:

  1. Patients with acute myocardial infarction within 30 days;
  2. a previous history of severe valvular heart disease,severe hepatic and renal insufficiency;severe cardiac dysfunction with EF≤40%;
  3. advanced cancer with a life expectancy of <12 months;
  4. Patients with abnormal coagulation function, Contraindications for antiplatelet drugs or unable to tolerate antiplatelet therapy;
  5. Pregnant and lactating patients;
  6. Multiple vessels involvement or multiple lesions requiring intervention treatment,left main artery lesions and coronary artery bypass graft lesions;
  7. Stent restenosis
  8. Thrombotic disease,severe calcified lesions(Judged by the operator, CAG showed class 2 or more severe calcified lesions),spontaneous dissection or ulcerative lesion,coronary ostial lesions (the lesion included should be an interval of greater than 3mm from the ostial of RCA or LAD), severe angulated lesions(>45°)
  9. diameter of collateral vessel≥ 2.25 mm requiring interventional therapy,type 1 coronary lesions(Patients with diameter of collateral vessel< 2.25 mm, who were not treated with DCB dilatation were also eligible).

Information from the National Library of Medicine

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


Contacts
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Contact: Fei Xia +8617702487875 xf19870421@126.com
Contact: Zhilin Miao +8617702487775 miaozl2049@sina.com

Locations
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China, Liaoning
The People's Hospital of Liaoning Province Not yet recruiting
Shenyang, Liaoning, China, 110016
Contact: Aijie Hou         
Contact: Xizhuang Bai         
Sponsors and Collaborators
The People's Hospital of Liaoning Province
Investigators
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Principal Investigator: Aijie Hou The People's Hospital of Liaoning Province

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Responsible Party: Zhilin Miao, Vice-Director of Department of Cardiology, The People's Hospital of Liaoning Province
ClinicalTrials.gov Identifier: NCT03155971     History of Changes
Other Study ID Numbers: CTC-91919
First Posted: May 16, 2017    Key Record Dates
Last Update Posted: May 16, 2017
Last Verified: May 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No

Keywords provided by Zhilin Miao, The People's Hospital of Liaoning Province:
Drug-Coated Balloon
Main Coronary Artery
De Novo Lesion

Additional relevant MeSH terms:
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Angina Pectoris
Angina, Stable
Angina, Unstable
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Chest Pain
Pain
Neurologic Manifestations
Signs and Symptoms
Paclitaxel
Albumin-Bound Paclitaxel
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action