Clinical trial NCT03076476: Coronary Microcirculatory and Bioresorbable Vascular Scaffolds
Official title: Evaluation of Microcirculatory Protection In Percutaneous REvascularisation With Bioresorbable Vascular Scaffolds Versus Metallic Drug-eluting Stents: a Device- and Implant Technique-based Comparison
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: CHD - Coronary Heart Disease
Angina, Stable
Myocardial Ischemia
Keywords: Coronary Stent
PCI
BVS
Index of microcirculatory resistance
Lead sponsor: Papworth Hospital NHS Foundation Trust
Sponsor class: OTHER_GOV
First posted: 2017-03-10
Enrollment: 36
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Angina and heart attacks are caused by narrowings in the coronary arteries (blood vessels) supplying the heart. These narrowings can be opened using a balloon and stent (angioplasty). Traditionally, stents are constructed from metal and are permanent. However, newer stents are being constructed from carbohydrate polymers (scaffolds), which allow them to reabsorb over time leaving no permanent implant. New data has suggested that these scaffolds appear to reduce recurrent angina and may alter the blood flow down the artery. However, it is not known whether this is due to the scaffolds themselves or the way the scaffolds are inserted. In this study we hope to measure the blood flow to the heart and assess changes in that flow during stent and scaffold insertion. It is also important to know whether these effects are durable and thus, a cohort of patients will return at 3-months to be restudied. These data are important to help us understand why blood flow is affected by stent/scaffold selection or device implantation technique and whether this results in better long-term outcomes.


Eligibility criteria: Inclusion Criteria:

1. Patient age \>18 years, \<75 years.
2. Lesion suitability for BVS deployment: target vessel calibre \>2.3mm and \<3.8mm reference diameter, without significant tortuosity or calcification.
3. Listed for single-vessel PCI procedure.
4. Lesion length≤28mm (to accommodate single BVS/DES)
5. Preserved left ventricular ejection fraction (EF≥50%).

Exclusion Criteria:

1. Patients with confirmed myocardial infarction within the preceding 2 months.
2. Allergy or intolerance to aspirin, clopidogrel, prasugrel or ticagrelor or contraindication to 12 months' dual antiplatelet therapy.
3. Contraindication to use of adenosine (asthma/chronic lung disease with documented bronchoreactivity).
4. Significant known comorbidity or terminal condition with life expectancy \<6 months.
5. Pregnancy.
6. Coagulopathy or warfarin treatment.
7. Significant renal impairment (baseline creatinine\>130 mmol/l).
8. Other comorbid condition that may affect microcirculatory function or troponin release (eg. Seropositive inflammatory conditions).
9. Inability to comply with follow-up requirements.
10. Target lesion in left mainstem, saphenous vein or arterial grafts.
11. Chronic total occlusion.

Primary outcomes:
measure: Change in IMR between baseline and post-stent/scaffold implantation.
timeFrame: During procedure
measure: Change in CFR between baseline and post-stent/scaffold implantation.
timeFrame: During procedure
Secondary outcomes:
measure: Incidence of troponin elevation post-PCI (MI4a).
timeFrame: Measured 6 hours after stent insertion
measure: Changes in IMR between baseline, post-implant and subsequent timepoints in subrandomized group.
timeFrame: 3 months follow up
measure: Incidence of post-PCI angina and quality of life by standardized Seattle angina questionnaire at telephone follow-up.
timeFrame: Up to 12 months
measure: Incidence of stent & scaffold expansion & malapposition adjudged by strut-level OCT analysis.
timeFrame: During index procedure and at 3 month follow up
measure: Incidence of stent/scaffold strut coverage/endothelialisation adjudged by strut-level OCT analysis.
timeFrame: During index procedure and at 3 month follow up
measure: Nature/phenotype of underlying target lesion plaque by OCT analysis.
timeFrame: During index procedure and at 3 month follow up
measure: Adverse events
timeFrame: At time points 1, 3, 6 & 12 months post-PCI
measure: Serious adverse events
timeFrame: At time points 1, 3, 6 & 12 months post-PCI
Other outcomes:
Locations:
city: Cambridge
country: United Kingdom
facility: Papworth Hospital NHS Foundation Trust
state: Cambridgeshire
Study officials:
affiliation: Papworth NHS Foundation Trust
name: Melissa Duckworth
role: STUDY_DIRECTOR
References:
citation: Aetesam-Ur-Rahman M, Zhao TX, Paques K, Oliveira J, Khialani B, Kyranis S, Braganza DM, Clarke SC, Bennett MR, West NEJ, Hoole SP. Coronary Flow Variations Following Percutaneous Coronary Intervention Affect Diastolic Nonhyperemic Pressure Ratios More Than the Whole Cycle Ratios. J Am Heart Assoc. 2022 May 3;11(9):e023554. doi: 10.1161/JAHA.121.023554. Epub 2022 Apr 26.