Side Branch FFR After Provisional Stenting

NCT03115580 | Completed Results FDA Device

• 1 other identifier: GCO 16-0204
• Study Type: interventional
• Target: 71
• Locations: 1 country
• Sites: 1

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.

Conditions

Coronary Artery Disease

Outcome Measures

Primary Outcomes (1)

• Number of Participants With Side Branch Compromise

  Number of participants with Side Branch (SB) compromise which is defined as SB DS \> 70%, or dissection or TIMI \< 3

  Day 1

Secondary Outcomes (5)

• Number of Participants With SB Dissection

  Day 1

• Number of Participants With TIMI < 3

  Day 1

• Number of Participants With SB DS >70%

  Day 1

• Number of Participants With FFR Device Success

  Day 1

• Number of Patients With FFR Wire Workhorse Capability

  Day 1

Study Arms (2)

Rotational atherectomy

ACTIVE COMPARATOR

Rotational atherectomy (RA)

Device: Rotational atherectomy

CBA/PTCA

ACTIVE COMPARATOR

Cutting Balloon Angioplasty (CBA) or Percutaneous transluminal coronary angioplasty (PTCA)

Device: Cutting Balloon Angioplasty

Interventions

Rotational atherectomy DEVICE

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.

Also known as: RA

Rotational atherectomy

Cutting Balloon Angioplasty DEVICE

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

Also known as: CBA

CBA/PTCA

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• stenosis ≥70% and \<100%, or
• 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.

You may not qualify if:

• 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)

Sponsors & Collaborators

• Icahn School of Medicine at Mount Sinai: lead

Study Sites (1)

Icahn School of Medicine at Mount Sinai and the Mount Sinai Hospital

New York, New York, 10029, United States

Location

MeSH Terms

Conditions

Coronary Artery Disease

Interventions

Atherectomy, Coronary

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Intervention Hierarchy (Ancestors)

Atherectomy; Angioplasty; Catheterization; Therapeutics; Myocardial Revascularization; Cardiac Surgical Procedures; Cardiovascular Surgical Procedures; Surgical Procedures, Operative; Endovascular Procedures; Vascular Surgical Procedures; Percutaneous Coronary Intervention; Minimally Invasive Surgical Procedures; Thoracic Surgical Procedures; Investigative Techniques

Results Point of Contact

• Title: Annapoorna S. Kini, MD
• Organization: Icahn School of Medicine at Mount Sinai

annapoorna.kini@mountsinai.org

212-241-4181

Study Officials

• Annapoorna Kini, MD, MRCO, FACC

  Icahn School of Medicine at Mount Sinai

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director Cardiac Cath lab

Study Record Dates

• First Submitted: April 3, 2017
• First Posted: April 14, 2017
• Study Start: May 2, 2017
• Primary Completion: March 26, 2019
• Study Completion: March 26, 2019
• Last Updated: May 14, 2020
• Results First Posted: May 8, 2020

Record last verified: 2020-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)