Coronary Microcirculatory and Bioresorbable Vascular Scaffolds

NCT03076476 | Completed DMC

• 1 other identifier: P02135
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

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.

Conditions

CHD - Coronary Heart Disease; Angina, Stable; Myocardial Ischemia

Keywords

Coronary Stent; PCI; BVS; Index of microcirculatory resistance

Outcome Measures

Primary Outcomes (2)

• Change in IMR between baseline and post-stent/scaffold implantation.

  IMR: index of microvascular resistance

  During procedure

• Change in CFR between baseline and post-stent/scaffold implantation.

  CFR: coronary flow reserve

  During procedure

Secondary Outcomes (8)

• Incidence of troponin elevation post-PCI (MI4a).

  Measured 6 hours after stent insertion

• Changes in IMR between baseline, post-implant and subsequent timepoints in subrandomized group.

  3 months follow up

• Incidence of post-PCI angina and quality of life by standardized Seattle angina questionnaire at telephone follow-up.

  Up to 12 months

• Incidence of stent & scaffold expansion & malapposition adjudged by strut-level OCT analysis.

  During index procedure and at 3 month follow up

• Incidence of stent/scaffold strut coverage/endothelialisation adjudged by strut-level OCT analysis.

  During index procedure and at 3 month follow up

Study Arms (3)

DES-std group

ACTIVE COMPARATOR

(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.

Device: Drug-Eluting Stent (DES) - standard(std)

DES-slow group

EXPERIMENTAL

(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.

Device: Drug-Eluting Stent (DES) - slow

BVS group

EXPERIMENTAL

(Bioresorbable Vascular Scaffold) Introduced after the interim analysis (phase 2) for comparison with DES-slow.

Device: Bioresorbable Vascular Scaffolds (BVS)

Interventions

Bioresorbable Vascular Scaffolds (BVS) DEVICE

Bioresorbable Vascular Scaffold. Introduced after the interim analysis (phase 2) for comparison with DES-slow.

Also known as: ABSORB

BVS group

Drug-Eluting Stent (DES) - slow DEVICE

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.

Also known as: Xience

DES-slow group

Drug-Eluting Stent (DES) - standard(std) DEVICE

Metallic DES implanted in standard fashion. To be compared with the DES-slow group at interim analysis at the end of phase 1 stage.

Also known as: Xience

DES-std group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Papworth Hospital NHS Foundation Trust: lead

Study Sites (1)

Papworth Hospital NHS Foundation Trust

Cambridge, Cambridgeshire, CB23 3RE, United Kingdom

Location

Related Publications (2)

• Aetesam-Ur-Rahman M, Zhao TX, Paques K, Oliveira J, Chiu YD, Duckworth M, Khialani B, Kyranis S, Bennett MR, West NEJ, Hoole SP. Evaluation of microcirculatory protection in percutaneous revascularisation: A stent implantation technique and device comparison. Catheter Cardiovasc Interv. 2024 Sep;104(3):462-471. doi: 10.1002/ccd.31155. Epub 2024 Jul 24.

  PMID: 39044651 DERIVED

• 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.

  PMID: 35470686 DERIVED

MeSH Terms

Conditions

Coronary Artery Disease; Angina, Stable; Myocardial Ischemia

Interventions

Drug-Eluting Stents

Condition Hierarchy (Ancestors)

Coronary Disease; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Angina Pectoris; Chest Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Stents; Prostheses and Implants; Equipment and Supplies

Study Officials

• Melissa Duckworth

  Papworth NHS Foundation Trust

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 26, 2017
• First Posted: March 10, 2017
• Study Start: February 1, 2017
• Primary Completion: March 10, 2021
• Study Completion: March 10, 2021
• Last Updated: April 22, 2022

Record last verified: 2022-04

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)