Coronary Microcirculatory and Bioresorbable Vascular Scaffolds

Not Applicable

Completed

• Conditions: Myocardial Ischemia; CHD - Coronary Heart Disease; Angina, Stable
• Interventions: Device: Drug-Eluting Stent (DES) - slow; Device: Bioresorbable Vascular Scaffolds (BVS); Device: Drug-Eluting Stent (DES) - standard(std)

• Registration Number: NCT03076476
• Lead Sponsor: Papworth Hospital NHS Foundation Trust

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-01-26
• Study Start: 2017-02-01
• Study First Submitted QC: 2017-03-06
• Study First Posted: 2017-03-10
• Primary Completion: 2021-03-10
• Study Completion: 2021-03-10
• Status Verified: 2022-04
• Last Update Submitted: 2022-04-21
• Last Update Posted: 2022-04-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 36

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
DES-slow group	Drug-Eluting Stent (DES) - slow	(DES: drug-eluting stent). Slow device inflation (mandated in the BVS IFU). To be compared with the DES-std group at interim analysis at the end of phase 1 stage. After the interim analysis DES-slow to be compared with BVS.
BVS group	Bioresorbable Vascular Scaffolds (BVS)	(Bioresorbable Vascular Scaffold) Introduced after the interim analysis (phase 2) for comparison with DES-slow.
DES-std group	Drug-Eluting Stent (DES) - standard(std)	(DES: drug-eluting stent). Metallic DES implanted in standard fashion. To be compared with the DES-slow group at interim analysis at the end of phase 1 stage.

Primary Outcome Measures

Name	Time	Method
Change in IMR between baseline and post-stent/scaffold implantation.	During procedure	IMR: index of microvascular resistance
Change in CFR between baseline and post-stent/scaffold implantation.	During procedure	CFR: coronary flow reserve

Secondary Outcome Measures

Name	Time	Method
Serious adverse events	At time points 1, 3, 6 & 12 months post-PCI	Serious adverse event assessed by clinical history and medical notes
Incidence of troponin elevation post-PCI (MI4a).	Measured 6 hours after stent insertion	Measuring serum troponin I levels by blood test
Changes in IMR between baseline, post-implant and subsequent timepoints in subrandomized group.	3 months follow up	IMR: index of microvascular resistance
Incidence of stent & scaffold expansion & malapposition adjudged by strut-level OCT analysis.	During index procedure and at 3 month follow up	OCT analysis of stent struts done quantitatively
Adverse events	At time points 1, 3, 6 & 12 months post-PCI	Adverse event assessed by clinical history and medical notes
Incidence of stent/scaffold strut coverage/endothelialisation adjudged by strut-level OCT analysis.	During index procedure and at 3 month follow up	OCT analysis of stent struts done quantitatively
Nature/phenotype of underlying target lesion plaque by OCT analysis.	During index procedure and at 3 month follow up	OCT analysis of lesion characteristics done quantitatively
Incidence of post-PCI angina and quality of life by standardized Seattle angina questionnaire at telephone follow-up.	Up to 12 months	Description: The Seattle Angina Questionnaire is a points based question and answer system where a overall score can be assessed and compared

Trial Locations

Locations (1)

Papworth Hospital NHS Foundation Trust; 🇬🇧 Cambridge, Cambridgeshire, United Kingdom