Optical Coherence Tomography to Improve Outcome for Coronary Revascularisation Using Bioresorbable Vascular Scaffolds (OPTICO-BVS)

Fully Bioresorbable Vascular Scaffolds (BVS) have been introduced with the objective to preserve native vessel geometry, allow for adaptive vessel remodeling with late lumen gain, restore physiological vasomotion, and avoid late adverse events including restenosis and scaffold thrombosis. Although randomized clinical trials in low risk patients to date suggest non-inferiority in terms of safety and efficacy compared with metallic DES, several reports have raised concerns regarding the scaffold thrombosis highlighting the importance of technical considerations regarding lesion preparation and scaffold expansion. OCT offers the opportunity to plan the procedure and optimize the implantation of BVS.

The hypothesis of the present study is that a strategy of OCT-guided PCI using BVS is superior to angiography-guided PCI (e.g. by selecting scaffold dimension on the basis of a pre-procedural OCT and applying corrective measures in case of suboptimal treatment result as indicated by OCT).

Study Overview

• Status: Terminated
• Conditions: Coronary Occlusion
• Intervention / Treatment: Other: OCT-guided PCI; Other: Angiography-guided PCI

• Study Type: Interventional
• Enrollment (Actual): 38
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Switzerland
  • Bern, Switzerland, 3010
    • Inselspital Bern

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Age ≥18 years.
2. Patient provides signed written informed consent before any study-specific procedure.
3. De novo native coronary artery disease with lesions that have a distal and proximal reference vessel diameter in the range between 2.25mm and 3.8mm.
4. Single or multi vessel disease. For multi vessel disease up to two vessels and three lesions treated at baseline with no more than two lesions per vessel. Vessel is defined as, left anterior descending, left circumflex, and right coronary arteries. Any branch within the vessel is considered part of the vessel.
5. Full revascularization of all lesions should be achievable (staged PCI not recommended)
6. Elective or ad hoc PCI, stable angina and acute coronary syndrome (NSTE-ACS and STEMI).
7. Angiographically significant (>50% visual estimation) stenosis present in at least one native coronary artery and evidence of ischemia.

Exclusion Criteria:

1. Subjects with left main lesion.
2. Aorto-ostial lesion location within 3 mm of the aorta junction (both right and left).
3. Subjects with restenosis or stent thrombosis in the target vessel.
4. Severely calcified lesions requiring rotablation.
5. Bifurcation with sidebranch >2.5mm or any sidebranch that possibly requires treatment with angulation >70°
6. Severe angulation (>90°) or excessive tortuosity (>two 45° angles)
7. Known renal insufficiency (serum creatinine clearance <45ml/min or receiving dialysis).
8. Vessel(s) and lesion(s) not amenable for PCI, for example diffuse disease.
9. Female of childbearing potential (age <50 years and last menstruation within the last 12 months), who did not undergo tubal ligation, ovariectomy or hysterectomy
10. Life expectancy less than 1 year.
11. Indication for oral anticoagulation
12. Known allergy against protocol-required medications including ASA, prasugrel, ticagrelor, clopidogrel, heparin, iodinated contrast (the latter in case it cannot be adequately premedicated)
13. History of bleeding diathesis or known coagulopathy.
14. Planned surgery within the next 6 months

Study Plan

How is the study designed?

Design Details

• Primary Purpose: DIAGNOSTIC
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: OCT-guided PCI; OCT before and after Stent implantation	Other: OCT-guided PCI; Patients assigned to the OCT-guided PCI strategy will undergo OCT prior to PCI to determine vessel and lesion dimensions and treatment strategy. OCT will be repeated at the end of the procedure and corrective PCI will aim to optimize the PCI result according to pre-specified criteria in terms of minimal lumen area, scaffold expansion, apposition, residual dissections or intra-scaffold thrombus formation
ACTIVE_COMPARATOR: Angiography-guided PCI; OCT after Stent implantation	Other: Angiography-guided PCI; Patients assigned to the OCT-guided PCI strategy will only undergo OCT after PCI to determine vessel and lesion dimensions and treatment strategy.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Minimal in-scaffold lumen area (mm2) as assessed by OCT	The lumen area is assessed by OCT	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of adverse events	Adverse events are defined as scaffold underexpansions, significant strut malappositions or uncovered struts, expansion asymmetries, any intrascaffold tissue, edge dissections, or restenoses (as assessed by OCT)	6 months
OCT imaging endpoints	Scaffold underexpansion, significant strut malapposition or uncovered struts, expansion asymmetry, any intrascaffold tissue, edge dissection, or restenosis. (as assessed by OCT)	6 months
Additional OCT imaging endpoints	Significant malapposed scaffold struts, %; Malapposed scaffold struts, %; Uncovered scaffold struts, %; Incomplete scaffold apposition area, mm2; Incomplete scaffold apposition distance, mm; Neointimal thickness, µm; Neointimal area, mm2; Volume obstruction, %	6 months
OCT imaging endpoints	Minimal in-scaffold lumen area, mm; Scaffold expansion, %; No of patients with scaffold expansion <80%; % lesions with significant malapposition; % malapposed struts	end of procedure
angiographic endpoints	acute lumen gain; in-scaffold minimal lumen diameter; in-segment minimal lumen diameter; in-scaffold % diameter stenosis; in-segment % diameter stenosis	end of procedure
angiographic endpoints	In-scaffold late lumen loss, mm; In-segment late lumen loss, mm; In-scaffold % diameter stenosis; In-segment % diameter stenosis; Binary restenosis, %; Percent diameter stenosis, %	6 months

Collaborators and Investigators

• Sponsor: University Hospital Inselspital, Berne
• Investigators: Study Chair: Lorenz Räber, MD PhD, Bern University Hospital, Switzerland; Principal Investigator: Stephan Windecker, Prof. MD, Bern University Hospital, Switzerland

Study record dates

Study Major Dates

• Study Start (ACTUAL): March 1, 2016
• Primary Completion (ACTUAL): December 1, 2017
• Study Completion (ACTUAL): May 1, 2019

Study Registration Dates

• First Submitted: January 22, 2016
• First Submitted That Met QC Criteria: February 11, 2016
• First Posted (ESTIMATE): February 17, 2016

Study Record Updates

• Last Update Posted (ACTUAL): March 10, 2022
• Last Update Submitted That Met QC Criteria: February 23, 2022
• Last Verified: February 1, 2022

More Information

Terms related to this study

• Keywords: Stents; Percutaneous Coronary Intervention
• Additional Relevant MeSH Terms: Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Coronary Disease; Coronary Occlusion
• Other Study ID Numbers: 2016-01-16

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO