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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT02528474
Other study ID # 1-2015-0041
Secondary ID
Status Terminated
Phase N/A
First received
Last updated
Start date September 30, 2015
Est. completion date April 20, 2017

Study information

Verified date February 2019
Source Yonsei University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Drug-coated balloon technology (DCB) has recently attracted considerable interest as a promising alternative treatment option, particularly in the setting of in-stent restenosis (ISR). Optical coherence tomographic finding of restenosis lesions in drug-eluting stents (DESs) after Balloon Angioplasty with Two Different Paclitaxel-Coated Balloons will be compared between two paclitaxel-coated balloon devices; Pantera Lux™ and SeQuent® Please.


Recruitment information / eligibility

Status Terminated
Enrollment 24
Est. completion date April 20, 2017
Est. primary completion date April 20, 2017
Accepts healthy volunteers No
Gender All
Age group 19 Years and older
Eligibility Inclusion Criteria:

- Patients = 19 years old

- Patients eligible for percutaneous coronary intervention

- Single or more lesion(s) of restenosis requiring angioplasty in drug-eluting stent

- Reference vessel diameter of target lesion =2.5 mm

Exclusion Criteria:

- Cardiogenic shock

- Bifurcation lesion or totally occluded lesion

- Unprotected left main trunk lesion

- Allergies or hypersensitivities to antiplatelet, anticoagulation therapy, contrast media, or paclitaxel

- Heavy calcified (definite calcified lesions on angiogram) or extremely tortuous lesions

- Pregnant women or women with potential childbearing

- Inability to follow the patient over the period of 1 year after enrollment, as assessed by the investigator

- Inability to understand or read the informed content

Study Design


Intervention

Device:
balloon angioplasty with Pantera Lux
Patient will be considered to be enrolled if ISR in DES was found by angiography. After randomization, patients will be treated with Pantera Lux for treatment of ISR. OCT will be performed just after balloon angioplasty for ISR lesion. Information will be collected and recorded on the treated study vessel including angiographic and OCT parameters. Follow-up OCT at 9 month will be performed.
balloon angioplasty with SeQuent Please
Patient will be considered to be enrolled if ISR in DES was found by angiography. After randomization, patients will be treated with SeQuent Please for treatment of ISR. OCT will be performed just after balloon angioplasty for ISR lesion. Information will be collected and recorded on the treated study vessel including angiographic and OCT parameters. Follow-up OCT at 9 month will be performed.

Locations

Country Name City State
Korea, Republic of Division of Cardiology, Department of Internal Medicine, Yonsei University College of Medicine Seoul

Sponsors (1)

Lead Sponsor Collaborator
Yonsei University

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type Measure Description Time frame Safety issue
Primary Neointimal thickness & area measured by OCT analysis 9 months
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