Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 27 of 88 for:    Recruiting, Not yet recruiting, Available Studies | Angioplasty

Debulking With Rotational Atherectomy Versus Balloon Angioplasty In Patients With In-stent Restenosis (ROTA-ISR)

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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03401203
Recruitment Status : Recruiting
First Posted : January 17, 2018
Last Update Posted : December 25, 2018
Sponsor:
Collaborator:
CardioVascular Research Foundation, Korea
Information provided by (Responsible Party):
Seung-Jung Park, Asan Medical Center

Brief Summary:
This study is to establish the primary hypothesis that debulking with rotational atherectomy (RA) followed by balloon angioplasty (BA) is superior to BA alone for lesion preparation in patients with coronary in-stent restenosis (ISR) regarding angiography-measured in-segment minimal lumen area at 1 year.

Condition or disease Intervention/treatment Phase
Coronary Vessels Procedure: Rotational atherectomy followed by balloon angioplasty Procedure: Balloon angioplasty Not Applicable

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 140 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Prospective, Open Label, Multi-center, Dual Arm, Randomized Trial : The ROTA-ISR (Debulking With Rotational Atherectomy Versus Balloon Angioplasty In Patients With In-stent Restenosis) Trial
Actual Study Start Date : May 8, 2018
Estimated Primary Completion Date : February 28, 2025
Estimated Study Completion Date : July 31, 2025

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Angioplasty

Arm Intervention/treatment
Experimental: rotational atherectomy followed by balloon angioplasty Procedure: Rotational atherectomy followed by balloon angioplasty
Percutaneous coronary intervention

Active Comparator: balloon angioplasty Procedure: Balloon angioplasty
Percutaneous coronary intervention




Primary Outcome Measures :
  1. In-segment minimal lumen diameter on angiographic [ Time Frame: 1 year ]

Secondary Outcome Measures :
  1. Device success rate [ Time Frame: 1 year ]
  2. Angiographic outcomes immediate after procedure [ Time Frame: 1 hour ]
    In-segment and in-stent minimal lumen diameter and diameter stenosis

  3. OCT outcomes immediate after procedure : In-segment and in-stent minimal lumen area [ Time Frame: 1 hour ]
  4. OCT outcomes immediate after procedure : In-segment and in-stent neointimal volume [ Time Frame: 1 hour ]
  5. Angiographic outcomes : In-segment and in-stent late loss, diameter stenosis [ Time Frame: 1 year ]
  6. OCT outcomes : in-segment and in-stent late lumen area, minimal lumen area loss [ Time Frame: 1 year ]
  7. composite event rate [ Time Frame: 1 year ]

    A composite event of following factors is defined as the occurrence of any event from these events and denoted that event as the union of these.

    • Death (cardiac, vascular, non-cardiovascular)
    • Myocardial infarction (periprocedural, spontaneous)
    • Stent thrombosis (definite/probable)
    • Stroke
    • Any revascularization
    • Target lesion revascularization (TLR)
    • Target vessel revascularization (TVR)
    • Clinically significant bleeding (BARC type 2,3,4,5)
    • Target lesion failure (cardiac death, target vessel MI or ischemia-driven TLR)
    • Target vessel failure (cardiac death, target vessel MI or ischemia-driven TVR)
    • A composite of all-cause death, MI, any repeat revascularization
    • A composite of cardiac death, target vessel MI, stroke, or clinically significant bleeding (Bleeding Academic Research Consortium (BARC) type 2,3,4,5)



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   19 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Men or women at least 19 years of age
  • Subjects with coronary In-stent restenosis planned revascularization
  • In-stent restenosis with neointimal hyperplasia evaluated by intravascular imaging
  • The patient or guardian agrees to the study protocol and the schedule of clinical follow-up, and provides informed, written consent, as approved by the appropriate Institutional Review Board/Ethical Committee of the respective clinical site.

Exclusion Criteria:

  • Complex lesion anatomy that disables rotational atherectomy
  • Any clinically significant abnormality identified at the screening visit, physical examination, laboratory tests, or electrocardiogram which, in the judgment of the Investigator, would preclude safe completion of the study.
  • Life expectancy < 1 years for any non-cardiac or cardiac causes
  • Unwillingness or inability to comply with the procedures described in this protocol.

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): NCT03401203


Contacts
Layout table for location contacts
Contact: Seung-jung Park, MD sjpark@amc.seoul.kr
Contact: Jung-hee Ham, RN 82230104728 cvcrc5@amc.seoul.kr

Locations
Layout table for location information
Korea, Republic of
Soon Chun Hyang University Hospital Bucheon Recruiting
Bucheon, Korea, Republic of
Contact: Nae-Hee Lee, MD       naeheelee@naver.com   
Principal Investigator: Nae-Hee Lee, MD         
Chungnam National University Hospital Not yet recruiting
Dae-jeon, Korea, Republic of
Contact: Si-Wan Choi, MD       siwanc@cnu.ac.kr   
Principal Investigator: Si-wan Choi, MD         
Daegu Catholic University Medical Center Not yet recruiting
Daegu, Korea, Republic of
Contact: Kee-Sik Kim, MD       kks7379@cu.ac.kr   
Principal Investigator: Kee-Sik Kim, MD         
Chonnam National University Hospital Recruiting
Gwangju, Korea, Republic of
Contact: Young-jun Hong, MD       hyj200@hanmail.net   
Principal Investigator: Young-jun Hong, MD         
Inje University Pusan Paik Hospital Not yet recruiting
Pusan, Korea, Republic of
Contact: Jae-Sik Jang, MD       jsjang71@gmail.com   
Principal Investigator: Jae-sik Jang, MD         
Asan Medical Center Recruiting
Seoul, Korea, Republic of
Contact: Seung-jung Park, MD       sjpark@amc.seoul.kr   
Principal Investigator: Seung-jung Park, MD         
Bundang CHA Hospital Recruiting
Sungnam, Korea, Republic of
Contact: Won-jang Kim, MD       mdwjkim@gmail.com   
Principal Investigator: Won-jang Kim, MD         
Sponsors and Collaborators
Seung-Jung Park
CardioVascular Research Foundation, Korea

Layout table for additonal information
Responsible Party: Seung-Jung Park, Professor, Division of Cardiology, Asan Medical Center, University of Ulsan, College of Medicine, Seoul, South Korea, Asan Medical Center
ClinicalTrials.gov Identifier: NCT03401203     History of Changes
Other Study ID Numbers: AMCCV2017-11
First Posted: January 17, 2018    Key Record Dates
Last Update Posted: December 25, 2018
Last Verified: December 2018

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Seung-Jung Park, Asan Medical Center:
ISR
ROTA
DEB
PCI