FAST Feasibility Study

NCT02470884 | Completed

• 1 other identifier: S2327
• Study Type: interventional
• Target: 33
• Locations: 3 countries
• Sites: 7

Brief Summary

A prospective multi-center, single arm feasibility study to assess the safety and performance of the Boston Scientific Fully Absorbable Scaffold.

Conditions

Coronary Artery Disease

Outcome Measures

Primary Outcomes (1)

• Clinical Procedural Success

  Percent diameter stenosis ≤30% and no in-hospital MACE (Death, MI or TLR)

  In-hospital (through discharge or 7 days from the index procedure, whichever is sooner)

Secondary Outcomes (1)

• In-scaffold late loss

  6 months

Study Arms (1)

FAST

EXPERIMENTAL

Subjects treated with the Boston Scientific Fully Absorbable Scaffold

Device: Boston Scientific Fully Absorbable Scaffold

Interventions

Boston Scientific Fully Absorbable Scaffold DEVICE

Attempt to implant the Boston Scientific Fully Absorbable Scaffold.

FAST

Eligibility Criteria

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

You may qualify if:

• Subject must be at least 18 years of age
• Subject (or legal guardian) understands the study requirements and the treatment procedures and provides written informed consent before any study-specific tests or procedures are performed
• Subject is eligible for percutaneous coronary intervention (PCI) and is an acceptable candidate for coronary artery bypass grafting (CABG)
• Subject has either:
• Symptomatic coronary artery disease with one of the following: stenosis \> 70%, abnormal fractional flow reserve (FFR), abnormal stress or imaging stress test, or elevated biomarkers prior to the procedure or Documented silent ischemia based on one of the following: abnormal fractional flow reserve (FFR), abnormal stress or imaging stress test, or elevated biomarkers prior to the procedure
• Subject is willing to comply with all protocol-required follow-up evaluation
• Target lesion must be \<12 mm in length with reference vessel diameter \>2.75 mm and \<3.25 mm
• Target lesion must have visually estimated stenosis \>50% and \<100% with thrombolysis in Myocardial Infarction (TIMI) flow \>1
• The target lesion must be successfully predilated Note: Successful predilatation refers to dilatation with a balloon catheter of appropriate length and diameter with ≤30% residual stenosis and no dissection greater than National Heart, Lung, Blood Institute (NHLBI) type C.

You may not qualify if:

• Subject has clinical symptoms and/or electrocardiogram (ECG) changes consistent with acute MI
• Subjects with unstable angina or recent MI (clinically diagnosed within the past 2 weeks) must have cardiac troponin (cTn) documented prior to the procedure and are excluded if cTn is \> 5x ULN
• Subject has cardiogenic shock, hemodynamic instability requiring inotropic or mechanical circulatory support, intractable ventricular arrhythmias, or ongoing intractable angina
• Non-target vessel or side branch has been treated with any type of PCI (e.g., balloon angioplasty, stent, cutting balloon, atherectomy) within 24 hours prior to the index procedure
• Target vessel has been treated with any type of PCI (e.g., balloon angioplasty, stent, cutting balloon, atherectomy) within 1 year prior to the index procedure
• Planned PCI or CABG after the index procedure
• Subject has a known allergy to contrast that cannot be adequately premedicated or to the study scaffold system or protocol-required concomitant medications (e.g., everolimus or structurally related compounds, polymer or individual components, all P2Y12 inhibitors, or aspirin)
• Subject has received an organ transplant or is on a waiting list for an organ transplant
• Subject is receiving or scheduled to receive chemotherapy within 30 days before or after the index procedure
• Subject has a known condition(s) of the following (as assessed prior to the index procedure):
• Other serious medical illness (e.g., cancer, congestive heart failure) that may reduce life expectancy to less than 24 months
• Current problems with substance abuse (e.g., alcohol, cocaine, heroin, etc.)
• Planned procedure that may cause non-compliance with the protocol or confound data interpretation
• Subject previously treated at any time with intravascular brachytherapy
• Subject is receiving chronic (\> 72 hours) anticoagulation therapy (i.e., heparin, coumadin) for indications other than acute coronary syndrome

Sponsors & Collaborators

• Boston Scientific Corporation: lead

Study Sites (7)

The Prince Charles Hospital

Chermside, Queensland, 4032, Australia

Location

St. Vincent's Hospital

Fitzroy, Victoria, 3065, Australia

Location

Peninsula Health

Frankston, Victoria, 3199, Australia

Location

Monash Medical Centre

Melbourne, Victoria, 3168, Australia

Location

P. Stradins University Hospital

Riga, LV-1002, Latvia

Location

Auckland City Hospital

Grafton, Auckland, 1023, New Zealand

Location

North Shore Hospital

Takapuna, Auckland, 0622, New Zealand

Location

Related Links

• Clinical Outcomes in Patients Treated With the Fully Absorbable, Everolimus-Eluting RENUVIATM Scaffold: Primary Endpoint Results from the FAST First Human Use Study

MeSH Terms

Conditions

Coronary Artery Disease

Condition Hierarchy (Ancestors)

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

Study Officials

• Sujth Seneviratne, MBBS

  MonashHeart, Southern Health

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 10, 2015
• First Posted: June 12, 2015
• Study Start: June 15, 2015
• Primary Completion: January 31, 2017
• Study Completion: February 2, 2022
• Last Updated: June 22, 2022

Record last verified: 2022-06

Locations

NZ (2); AU (4); LA (1)