Clinical trial NCT02683356: Optical Coherence Tomography to Improve Outcome for Coronary Revascularisation Using Bioresorbable Vascular Scaffolds
Official title: Optical Coherence Tomography to Improve Outcome for Coronary Revascularisation Using Bioresorbable Vascular Scaffolds
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Coronary Occlusion
Keywords: Percutaneous Coronary Intervention
Stents
Lead sponsor: Insel Gruppe AG, University Hospital Bern
Sponsor class: OTHER
First posted: 2016-02-17
Enrollment: 38
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

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).


Eligibility criteria: 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

Primary outcomes:
measure: Minimal in-scaffold lumen area (mm2) as assessed by OCT
timeFrame: 6 months
Secondary outcomes:
measure: Number of adverse events
timeFrame: 6 months
measure: OCT imaging endpoints
timeFrame: 6 months
measure: Additional OCT imaging endpoints
timeFrame: 6 months
measure: OCT imaging endpoints
timeFrame: end of procedure
measure: angiographic endpoints
timeFrame: end of procedure
measure: angiographic endpoints
timeFrame: 6 months
Other outcomes:
Locations:
city: Bern
country: Switzerland
facility: Inselspital Bern
Study officials:
affiliation: Bern University Hospital, Switzerland
name: Lorenz Räber, MD PhD
role: STUDY_CHAIR
affiliation: Bern University Hospital, Switzerland
name: Stephan Windecker, Prof. MD
role: PRINCIPAL_INVESTIGATOR
References: