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Side Branch FFR After Provisional Stenting (ORBID-FFR)

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: NCT03115580
Recruitment Status : Completed
First Posted : April 14, 2017
Results First Posted : May 8, 2020
Last Update Posted : May 14, 2020
Sponsor:
Information provided by (Responsible Party):
Annapoorna Kini, Icahn School of Medicine at Mount Sinai

Brief Summary:

The purpose of this study is to predict any changes in the side branch after stenting the main branch blood vessel using three dimensional intravascular images. (Frequency domain optical coherence tomography FD OCT).

Optical coherence tomography (OCT) is an established medical imaging technique that uses light to capture high-resolution, three-dimensional images of blood vessels. These images will be used before and after implanting the stent in the main blood vessel. Fractional Flow Reserve (FFR) test, which makes it possible for the interventional cardiologist to calculate blood flow across an area of a coronary artery, will be done after stenting and will help to determine if there are any changes in the side branch blood flow.


Condition or disease Intervention/treatment Phase
Coronary Artery Disease Device: Rotational atherectomy Device: Cutting Balloon Angioplasty Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 71 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Optical Coherence Tomography Predictors of Functionally Significant Side Branch Compromise After Provisional Main Vessel Stenting In Calcific Coronary Artery Disease Assessed by Fractional Flow Reserve
Actual Study Start Date : May 2, 2017
Actual Primary Completion Date : March 26, 2019
Actual Study Completion Date : March 26, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Rotational atherectomy
Rotational atherectomy (RA)
Device: Rotational atherectomy
Rotational atherectomy for the treatment of bifurcation lesions to remove plaque with minimal injury to adjacent normal arterial segments and potentially reduce plaque shifting, the "snow plow" effect.
Other Name: RA

Active Comparator: CBA/PTCA
Cutting Balloon Angioplasty (CBA) or Percutaneous transluminal coronary angioplasty (PTCA)
Device: Cutting Balloon Angioplasty
Cutting balloon is a special balloon catheter with three or four microsurgical blades attached longitudinally to its surface, suitable for creating discrete longitudinal incisions in the atherosclerotic target coronary segment during balloon inflation. Lesion preparation will be performed using Cutting Balloon or conventional balloon
Other Name: CBA




Primary Outcome Measures :
  1. Number of Participants With Side Branch Compromise [ Time Frame: Day 1 ]
    Number of participants with Side Branch (SB) compromise which is defined as SB DS > 70%, or dissection or TIMI < 3


Secondary Outcome Measures :
  1. Number of Participants With SB Dissection [ Time Frame: Day 1 ]
    Number of participants with SB dissection

  2. Number of Participants With TIMI < 3 [ Time Frame: Day 1 ]
    Number of participants with TIMI flow grade < 3

  3. Number of Participants With SB DS >70% [ Time Frame: Day 1 ]
    Number of participants with Side Branch Diameter Stenosis (DS) > 70%

  4. Number of Participants With FFR Device Success [ Time Frame: Day 1 ]
    Number of Participants with successfully deliver Fractional Flow Reserve (FFR) wire to desired SB distal segment

  5. Number of Patients With FFR Wire Workhorse Capability [ Time Frame: Day 1 ]
    FFR Wire Workhorse Capability - Number of patients in which FFR wire was able to serve as rail to deliver additional interventional devices to target SB lesion



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

Inclusion Criteria:

  • All patients over 18 years of age presenting with stable coronary artery disease.
  • Patients must have a clinical indication for coronary intervention.
  • Creatinine Kinase Myocardial-Band Isoenzyme (CK-MB) must be less than or equal to the upper limit of lab normal (ULN) value within eight hours prior to the procedure.
  • The target lesion must be a de novo calcified bifurcation coronary lesion that hasn't been previously treated with any interventional procedure for which provisional main vessel stenting strategy is planned after reviewing angiogram.
  • The target vessel must be a native coronary artery with

    1. stenosis ≥70% and <100%, or
    2. Stenosis ≥50% and <70% with evidence of clinical ischemia via positive stress test, or FFR ≤ 0.8, or IVUS or OCT minimal lumen area ≤ 4.0 mm2.
  • The target lesion should have SB DS 30 - 70%.
  • The target main vessel reference diameter must be ≥2.5 mm and ≤ 4.0 mm.
  • The SB reference diameter must be > 2 mm by coronary angiogram.
  • The target vessel must have a Thrombolysis in Myocardial Infarction (TIMI) flow grade 3 at baseline.

Exclusion Criteria:

  • Patients with ostial left main artery lesions or ostial right coronary artery lesions
  • Female patients with child bearing potential not taking adequate contraceptives or currently breastfeeding
  • Known allergy to acetylsalicylic acid or clopidogrel.
  • Planned surgery within 12 months.
  • History of bleeding diathesis
  • Major surgery within 15 days
  • Life expectancy < 12 months.
  • Patients with kidney dysfunction (CrCl<30)

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): NCT03115580


Locations
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United States, New York
Icahn School of Medicine at Mount Sinai and the Mount Sinai Hospital
New York, New York, United States, 10029
Sponsors and Collaborators
Icahn School of Medicine at Mount Sinai
Investigators
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Principal Investigator: Annapoorna Kini, MD, MRCO, FACC Icahn School of Medicine at Mount Sinai
  Study Documents (Full-Text)

Documents provided by Annapoorna Kini, Icahn School of Medicine at Mount Sinai:
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Responsible Party: Annapoorna Kini, Director Cardiac Cath lab, Icahn School of Medicine at Mount Sinai
ClinicalTrials.gov Identifier: NCT03115580    
Other Study ID Numbers: GCO 16-0204
First Posted: April 14, 2017    Key Record Dates
Results First Posted: May 8, 2020
Last Update Posted: May 14, 2020
Last Verified: May 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Additional relevant MeSH terms:
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Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases