CClinicalTrials.gg
Status unknownNCT03155971Updated May 16, 2017

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

An interventional study of Paclitaxel-Coated Balloon in Stable Angina Pectoris and Unstable Angina Pectoris, sponsored by The People's Hospital of Liaoning Province. Status unknown at 1 site in China. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2017-05-16.

Sponsored by The People's Hospital of Liaoning Province · Not applicable, Interventional, and Treatment

The sponsor has not verified this record recently (last verified May 2017), so the status shown — last known as Not yet recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
60
Allocation
Not applicable
Ages
18 Years to 75 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Stable Angina Pectoris
  • Unstable Angina Pectoris

Keywords

  • Drug-Coated Balloon
  • Main Coronary Artery
  • De Novo Lesion
03

In context

Angina Pectoris

519 studies on the registry are indexed under Angina Pectoris; 82 are open to participants now.

This study's planned enrollment of 60 is below the median of 123 across 336 interventional studies indexed under Angina Pectoris.

Browse Angina Pectoris studies →

Lead sponsor

The People's Hospital of Liaoning Province is the lead sponsor of 2 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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).
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Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
60 participants (estimated)

Study arms

  • 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

Interventions

  • DevicePaclitaxel-Coated Balloon

    SeQuent ® Please; B.Braun, Melsungen, Germany

    Also known as: Drug-coated balloon (DCB)

06

What researchers measure

Primary outcomes

  1. QCA late lumen loss

    minimal lumen diameter at post-procedure minus minimal lumen diameter at 9 months follow-up measured by QCA(quantitative coronary angiography)

    Time frame: Immediately after the procedure and at 9 months follow-up

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Study locations

1 site
  • The People's Hospital of Liaoning Province
    Shenyang, Liaoning 110016, China
    • Aijie Hou · Contact
    • Xizhuang Bai · Contact
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 16, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03155971
Lead sponsor
The People's Hospital of Liaoning Province
Responsible party
Zhilin Miao (Vice-Director of Department of Cardiology, The People's Hospital of Liaoning Province) — Principal investigator
First posted
May 16, 2017
Start date
Jul 1, 2017 (estimated)
Primary completion
Jan 1, 2019 (estimated)
Completion
Feb 1, 2019 (estimated)
Last update
May 16, 2017

Study contacts

Fei Xia
Contact
xf19870421@126.com
+8617702487875
Zhilin Miao
Contact
miaozl2049@sina.com
+8617702487775
Aijie Hou
principal investigator · The People's Hospital of Liaoning Province

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in May 2017. You cannot join it, but the record below documents what was studied.

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