Optical Coherence Tomography to Improve Outcome for Coronary Revascularisation Using Bioresorbable Vascular Scaffolds

NCT02683356 | Terminated

• 1 other identifier: 2016-01-16
• Study Type: interventional
• Target: 38
• Locations: 1 country
• Sites: 1

Brief Summary

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).

Conditions

Coronary Occlusion

Keywords

Percutaneous Coronary Intervention; Stents

Outcome Measures

Primary Outcomes (1)

• Minimal in-scaffold lumen area (mm2) as assessed by OCT

  The lumen area is assessed by OCT

  6 months

Secondary Outcomes (6)

• Number of adverse events

  6 months

• OCT imaging endpoints

  6 months

• Additional OCT imaging endpoints

  6 months

• OCT imaging endpoints

  end of procedure

• angiographic endpoints

  end of procedure

Study Arms (2)

OCT-guided PCI

ACTIVE COMPARATOR

OCT before and after Stent implantation

Other: OCT-guided PCI

Angiography-guided PCI

ACTIVE COMPARATOR

OCT after Stent implantation

Other: Angiography-guided PCI

Interventions

OCT-guided PCI OTHER

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

OCT-guided PCI

Angiography-guided PCI OTHER

Patients assigned to the OCT-guided PCI strategy will only undergo OCT after PCI to determine vessel and lesion dimensions and treatment strategy.

Angiography-guided PCI

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥18 years.
• Patient provides signed written informed consent before any study-specific procedure.
• 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.
• 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.
• Full revascularization of all lesions should be achievable (staged PCI not recommended)
• Elective or ad hoc PCI, stable angina and acute coronary syndrome (NSTE-ACS and STEMI).
• Angiographically significant (\>50% visual estimation) stenosis present in at least one native coronary artery and evidence of ischemia.

You may not qualify if:

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

Sponsors & Collaborators

• Insel Gruppe AG, University Hospital Bern: lead

Study Sites (1)

Inselspital Bern

Bern, 3010, Switzerland

Location

MeSH Terms

Conditions

Coronary Occlusion

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases

Study Officials

• Lorenz Räber, MD PhD

  Bern University Hospital, Switzerland

  STUDY CHAIR

• Stephan Windecker, Prof. MD

  Bern University Hospital, Switzerland

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 22, 2016
• First Posted: February 17, 2016
• Study Start: March 1, 2016
• Primary Completion: December 1, 2017
• Study Completion: May 1, 2019
• Last Updated: March 10, 2022

Record last verified: 2022-02

Data Sharing

• IPD Sharing: Will not share

Locations

CH (1)